A Phase 3 interventional study of Oral semaglutide and Placebo in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 66 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 521 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent.
For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will remain on 3 mg for the entire treatment period (26 weeks)
Drug: Oral semaglutide
Subjects will receive 3 mg for for the first 4 weeks, 7 mg for the remainder of the treatment period
Drug: Oral semaglutide
Subjects will receive 3 mg for the first 4 weeks, 7 mg for the next 4 weeks and 14 mg for the remainder of the treatment period
Drug: Oral semaglutide
Subjects will receive placebo tablets for the entire treatment period
Drug: Placebo
Tablets to be taken once-daily for 26 weeks
Tablets to be taken once-daily for 26 weeks
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Body Weight (Kilograms [kg])
Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile
Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)
Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Body Weight (Percentage [%])
Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Body Mass Index (BMI)
Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Waist Circumference
Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)
Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey
SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)
Number of participants who achieved HbA1c \< 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)
Number of participants who achieved HbA1c \<= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)
Number of participants who achieved HbA1c reduction \>= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)
Number of participants who achieved body weight loss \>= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)
Number of participants who achieved body weight loss \>= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)
Number of participants who achieved body weight loss \>= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)
Number of participants who achieved HbA1c \< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)
Number of participants who achieved HbA1c reduction \>= 1% (10.9 mmol/mol) and body weight loss \>= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Time From First Dose to Initiation of Rescue Medication
Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomization and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomization and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: From baseline (Week 0) to Week 26
Semaglutide Plasma Concentrations
Semaglutide plasma concentrations at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26: post dose any time
Change From Baseline in Haematology - Haematocrit (Ratio to Baseline)
Change from baseline (week 0) in haematocrit (measured in %) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline)
Change from baseline (week 0) in haemoglobin (measured in millimoles per liter \[mmol/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Haematology - Leucocytes (Ratio to Baseline)
Change from baseline (week 0) in leucocytes (measured in 10\^9 per liter \[10\^9/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline)
Change from baseline (week 0) in thrombocytes (measured in 10\^9/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Change from baseline (week 0) in basophils, eosinophils, lymphocytes, monocytes and neutrophils at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Urea (Ratio to Baseline)
Change from baseline (week 0) in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline)
Change from baseline (week 0) in creatinine (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline)
Change from baseline (week 0) in alanine aminotransferase (measured in units per liter \[U/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline)
Change from baseline (week 0) in aspartate aminotransferase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline)
Change from baseline (week 0) in alkaline phosphatase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline)
Change from baseline (week 0) in total bilirubin (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Amylase (Ratio to Baseline)
Change from baseline (week 0) in amylase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Lipase (Ratio to Baseline)
Change from baseline (week 0) in lipase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline)
Change from baseline (week 0) in creatine kinase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Calcium (Ratio to Baseline)
Change from baseline (week 0) in calcium (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Potassium (Ratio to Baseline)
Change from baseline (week 0) in potassium (measured in milliequivalents per liter \[mEq/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Sodium (Ratio to Baseline)
Change from baseline (week 0) in sodium (measured in mEq/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Albumin (Ratio to Baseline)
Change from baseline (week 0) in albumin (measured in g/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Calcitonin (Ratio to Baseline)
Change from baseline (week 0) in calcitonin (measured in picograms per milliliter \[pg/mL\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Pulse Rate
Change from baseline (week 0) in pulse rate at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Systolic Blood Pressure
Change from baseline (week 0) in systolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Diastolic Blood Pressure
Change from baseline (week 0) in diastolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Electrocardiogram (ECG) Category
Change from baseline (week 0) in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last dose of trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Physical Examination Category
Change from baseline (week 0) in physical examination category at week 26 is presented. The physical examination shift in findings were categorized as normal, abnormal NCS and abnormal CS and are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Change From Baseline in Eye Examination Category
Change from baseline (week 0) in eye examination category at week 26 is presented. Eye examination shift in findings were categorized as normal, abnormal NCS and abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Baseline (Week 0), Week 26
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Up to 31 weeks
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Up to 31 weeks
Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Up to 31 weeks
Anti-semaglutide Binding Antibody Levels
Anti-semaglutide binding antibody levels measured anytime during post-baseline visits (week 0 to week 31) are presented. The outcome data are presented as percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.
Time frame: Up to 31 weeks
Number of Participants With Anti-semaglutide Binding Antibodies
Number of participants who had anti-semaglutide binding antibody levels anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participants-investigator contact, and death for participants who died before any of the above.
Time frame: Up to 31 weeks
Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1
Number of participants who had anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.
Time frame: Up to 31 weeks
The trial was conducted at 52 sites in 3 countries and Region China (China mainland and Taiwan) as follows: China mainland (37 sites), Taiwan (3 sites); Hungary (4 sites), Serbia (2 sites) and Ukraine (6 sites).
| Milestone | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Started | 130 | 130 | 130 | 131 |
| Treated | 130 | 130 | 129 | 131 |
| Full analysis set | 130 | 130 | 130 | 131 |
| Safety analysis set | 130 | 130 | 129 | 131 |
| Completed | 126 | 126 | 124 | 124 |
| Not completed | 4 | 4 | 6 | 7 |
| Withdrew: Withdrawal by subject | 3 | 2 | 6 | 6 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 1 | 2 | 0 | 0 |
Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Percentage of HbA1c | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) | -1.1 ± 0.7 | -1.5 ± 0.8 | -1.6 ± 1.0 | -0.2 ± 0.9 |
Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Kg | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Body Weight (Kilograms [kg]) | -1.1 ± 3.3 | -2.2 ± 3.4 | -3.1 ± 3.7 | -1.1 ± 2.7 |
Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| milligrams per deciliter (mg/dL) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | -19.07 ± 32.44 | -32.28 ± 27.95 | -32.50 ± 24.91 | 0.00 ± 27.49 |
Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| mg/dL | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -29.4 ± 29.3 | -43.0 ± 36.1 | -44.5 ± 36.9 | -10.3 ± 37.5 |
Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| mg/dL | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals) | -14.5 ± 34.2 | -20.0 ± 39.9 | -27.9 ± 40.6 | -6.7 ± 35.6 |
Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Percentage change | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Body Weight (Percentage [%]) | -1 ± 4 | -3 ± 4 | -4 ± 5 | -1 ± 3 |
Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| kilograms per square meter (kg/m^2) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Body Mass Index (BMI) | -0.4 ± 1.2 | -0.8 ± 1.2 | -1.1 ± 1.3 | -0.4 ± 0.9 |
Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| centimetres (cm) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Waist Circumference | -2.1 ± 4.5 | -2.2 ± 4.8 | -2.8 ± 4.4 | -1.4 ± 3.3 |
Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Ratio of total cholesterol | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 0.99 ± 14.75 | 0.98 ± 16.62 | 0.94 ± 19.92 | 1.00 ± 14.45 |
Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Ratio of LDL cholesterol | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.00 ± 29.65 | 1.00 ± 28.35 | 0.94 ± 31.12 | 1.00 ± 25.32 |
Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Ratio of HDL cholesterol | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.03 ± 15.78 | 1.02 ± 15.41 | 1.02 ± 17.72 | 1.04 ± 14.61 |
Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Ratio of triglycerides | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.96 ± 45.32 | 0.90 ± 45.56 | 0.87 ± 51.82 | 0.93 ± 49.08 |
SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Units on a score | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Physical functioning | 0.25 ± 4.83 | 0.97 ± 5.16 | 0.34 ± 4.24 | 0.87 ± 4.98 |
| Role physical | 0.34 ± 5.70 | 0.43 ± 5.83 | -0.00 ± 5.02 | 0.33 ± 7.50 |
| Bodily pain | 0.11 ± 8.72 | -0.86 ± 8.19 | -0.34 ± 6.56 | 0.49 ± 8.40 |
| General health | 2.01 ± 7.14 | 2.51 ± 7.52 | 1.32 ± 8.61 | 1.17 ± 5.91 |
| Vitality | 1.23 ± 7.62 | -0.23 ± 6.96 | 0.54 ± 8.02 | 0.49 ± 6.35 |
| Social functioning | 0.22 ± 6.26 | 0.25 ± 7.22 | -0.60 ± 6.18 | 0.98 ± 7.04 |
| Role emotional | 0.46 ± 6.94 | 0.58 ± 8.34 | 0.33 ± 7.03 | -0.04 ± 9.03 |
| Mental health | 0.22 ± 7.59 | -0.38 ± 7.96 | -0.30 ± 7.78 | 0.05 ± 6.99 |
| Physical component score | 0.66 ± 5.21 | 0.88 ± 4.98 | 0.39 ± 4.60 | 0.94 ± 4.71 |
| Mental component score | 0.51 ± 6.86 | -0.15 ± 7.65 | -0.10 ± 6.44 | 0.08 ± 6.88 |
Number of participants who achieved HbA1c \< 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 75 | 100 | 92 | 27 |
| No | 39 | 17 | 24 | 79 |
Number of participants who achieved HbA1c \<= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 53 | 76 | 76 | 12 |
| No | 61 | 41 | 40 | 94 |
Number of participants who achieved HbA1c reduction \>= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 67 | 89 | 87 | 19 |
| No | 47 | 28 | 29 | 87 |
Number of participants who achieved body weight loss \>= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 33 | 49 | 62 | 28 |
| No | 81 | 68 | 54 | 78 |
Number of participants who achieved body weight loss \>= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 17 | 29 | 43 | 11 |
| No | 98 | 90 | 73 | 95 |
Number of participants who achieved body weight loss \>= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 5 | 7 | 12 | 0 |
| No | 110 | 112 | 104 | 106 |
Number of participants who achieved HbA1c \< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 54 | 80 | 84 | 19 |
| No | 60 | 37 | 32 | 87 |
Number of participants who achieved HbA1c reduction \>= 1% (10.9 mmol/mol) and body weight loss \>= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Yes | 26 | 43 | 53 | 10 |
| No | 88 | 74 | 63 | 96 |
Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomization and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomization and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Days | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Time From First Dose to Initiation of Rescue Medication | NA (NA to NA) | NA (NA to NA) | — | NA (NA to NA) |
Semaglutide plasma concentrations at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
| nanomoles per liter (nmol/L) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg |
|---|---|---|---|
| Semaglutide Plasma Concentrations | 4.36 ± 103.74 | 11.22 ± 106.34 | 17.71 ± 232.82 |
Change from baseline (week 0) in haematocrit (measured in %) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of haematocrit | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Haematology - Haematocrit (Ratio to Baseline) | 1.00 ± 7.14 | 1.00 ± 8.10 | 1.00 ± 6.15 | 1.00 ± 14.42 |
Change from baseline (week 0) in haemoglobin (measured in millimoles per liter \[mmol/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of haemoglobin | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline) | 1.01 ± 6.00 | 1.00 ± 6.82 | 1.00 ± 6.17 | 1.00 ± 7.50 |
Change from baseline (week 0) in leucocytes (measured in 10\^9 per liter \[10\^9/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of leucocytes | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Haematology - Leucocytes (Ratio to Baseline) | 1.03 ± 18.79 | 1.01 ± 22.23 | 1.04 ± 22.60 | 1.03 ± 20.80 |
Change from baseline (week 0) in thrombocytes (measured in 10\^9/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of thrombocytes | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline) | 1.03 ± 23.24 | 1.01 ± 17.69 | 1.04 ± 17.55 | 1.02 ± 19.98 |
Change from baseline (week 0) in basophils, eosinophils, lymphocytes, monocytes and neutrophils at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| 10^9 cells per liters (10^9 cells/L) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Basophils | 0.00 ± 0.06 | -0.01 ± 0.06 | -0.01 ± 0.06 | -0.01 ± 0.07 |
| Eosinophils | 0.01 ± 0.10 | 0.02 ± 0.10 | 0.02 ± 0.12 | 0.01 ± 0.08 |
| Lymphocytes | 0.05 ± 0.43 | -0.03 ± 0.49 | -0.09 ± 0.49 | 0.02 ± 0.46 |
| Monocytes | 0.01 ± 0.12 | -0.00 ± 0.16 | 0.01 ± 0.16 | 0.01 ± 0.15 |
| Neutrophils | 0.18 ± 0.98 | 0.06 ± 1.44 | 0.28 ± 1.19 | 0.21 ± 1.14 |
Change from baseline (week 0) in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of urea | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Urea (Ratio to Baseline) | 1.02 ± 21.23 | 1.00 ± 24.90 | 1.02 ± 23.12 | 1.07 ± 23.97 |
Change from baseline (week 0) in creatinine (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of creatinine | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline) | 1.03 ± 10.39 | 1.02 ± 13.25 | 1.03 ± 11.50 | 0.99 ± 11.49 |
Change from baseline (week 0) in alanine aminotransferase (measured in units per liter \[U/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of alanine aminotransferase | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline) | 0.88 ± 44.27 | 0.89 ± 45.23 | 0.85 ± 47.44 | 0.88 ± 42.72 |
Change from baseline (week 0) in aspartate aminotransferase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of aspartate aminotransferase | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline) | 0.91 ± 30.50 | 0.91 ± 34.42 | 0.90 ± 35.09 | 0.89 ± 38.14 |
Change from baseline (week 0) in alkaline phosphatase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of alkaline phosphatase | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline) | 0.94 ± 15.14 | 0.92 ± 20.54 | 0.95 ± 17.83 | 0.95 ± 13.83 |
Change from baseline (week 0) in total bilirubin (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of total bilirubin | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline) | 0.89 ± 34.97 | 0.84 ± 32.62 | 0.85 ± 41.55 | 0.95 ± 39.68 |
Change from baseline (week 0) in amylase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of amylase | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Amylase (Ratio to Baseline) | 1.09 ± 23.53 | 1.20 ± 27.17 | 1.11 ± 21.64 | 1.05 ± 26.52 |
Change from baseline (week 0) in lipase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of lipase | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Lipase (Ratio to Baseline) | 1.24 ± 43.99 | 1.60 ± 55.40 | 1.35 ± 51.48 | 1.05 ± 32.22 |
Change from baseline (week 0) in creatine kinase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of creatine kinase | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline) | 1.06 ± 67.51 | 0.96 ± 48.18 | 1.00 ± 46.25 | 0.93 ± 58.87 |
Change from baseline (week 0) in calcium (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of calcium | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Calcium (Ratio to Baseline) | 0.98 ± 6.66 | 0.97 ± 4.87 | 0.98 ± 4.52 | 0.97 ± 3.79 |
Change from baseline (week 0) in potassium (measured in milliequivalents per liter \[mEq/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of potassium | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Potassium (Ratio to Baseline) | 1.02 ± 9.73 | 1.01 ± 8.96 | 1.00 ± 9.94 | 1.01 ± 9.98 |
Change from baseline (week 0) in sodium (measured in mEq/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of sodium | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Sodium (Ratio to Baseline) | 1.00 ± 1.49 | 1.00 ± 1.46 | 1.00 ± 1.42 | 1.00 ± 1.32 |
Change from baseline (week 0) in albumin (measured in g/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of albumin | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Albumin (Ratio to Baseline) | 1.00 ± 4.07 | 0.99 ± 4.73 | 0.99 ± 4.41 | 0.99 ± 3.95 |
Change from baseline (week 0) in calcitonin (measured in picograms per milliliter \[pg/mL\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Ratio of calcitonin | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Calcitonin (Ratio to Baseline) | 1.01 ± 23.53 | 1.09 ± 39.69 | 1.15 ± 42.68 | 0.98 ± 46.93 |
Change from baseline (week 0) in pulse rate at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Beats per minute (beats/min) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Pulse Rate | 2 ± 9 | 4 ± 9 | 5 ± 9 | 1 ± 9 |
Change from baseline (week 0) in systolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| millimeters of mercury (mmHg) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Systolic Blood Pressure | 1 ± 13 | -2 ± 12 | -4 ± 13 | -2 ± 13 |
Change from baseline (week 0) in diastolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| mmHg | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Diastolic Blood Pressure | 0 ± 9 | -1 ± 8 | -2 ± 9 | -2 ± 9 |
Change from baseline (week 0) in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last dose of trial product plus 38 days or the end-date for the in-trial observation period.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Normal (week 0) to normal (week 26) | 53 | 61 | 59 | 58 |
| Normal (week 0) to abnormal NCS (week 26) | 12 | 11 | 9 | 5 |
| Normal (week 0) to abnormal CS (week 26) | 1 | 3 | 1 | 3 |
| Abnormal NCS (week 0) to normal (week 26) | 9 | 11 | 19 | 12 |
| Abnormal NCS (week 0) to abnormal NCS (week 26) | 26 | 23 | 23 | 33 |
| Abnormal NCS (week 0) to abnormal CS (week 26) | 2 | 0 | 1 | 0 |
| Abnormal CS (week 0) to normal (week 26) | 6 | 4 | 2 | 5 |
| Abnormal CS (week 0) to abnormal NCS (week 26) | 1 | 1 | 1 | 1 |
| Abnormal CS (week 0) to abnormal CS (week 26) | 11 | 9 | 4 | 4 |
Change from baseline (week 0) in physical examination category at week 26 is presented. The physical examination shift in findings were categorized as normal, abnormal NCS and abnormal CS and are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Cardiovascular system - Normal (week 0) to normal (week 26) | 113 | 118 | 115 | 115 |
| Cardiovascular system - Normal (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 1 |
| Cardiovascular system - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Cardiovascular system - Abnormal NCS (week 0) to normal (week 26) | 3 | 2 | 0 | 0 |
| Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26) | 5 | 2 | 1 | 4 |
| Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Cardiovascular system - Abnormal CS (week 0) to normal (week 26) | — | — | — | 0 |
| Cardiovascular system - Abnormal CS (week 0) to abnormal NCS (week 26) | — | — | — | 0 |
| Cardiovascular system - Abnormal CS (week 0) to abnormal CS (week 26) | — | — | — | 1 |
| Central and Peripheral Nervous System - Normal (week 0) to normal (week 26) | 119 | 121 | 116 | 120 |
| Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Central and Peripheral Nervous System - Abnormal NCS (week 0) to normal (week 26) | 0 | — | — | 0 |
| Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 | — | — | 1 |
| Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | — | — | 0 |
| Central and Peripheral Nervous System - Abnormal CS (week 0) to normal (week 26) | — | 0 | — | — |
| Central and Peripheral Nervous System - Abnormal CS (week 0) to abnormal NCS (week 26) | — | 0 | — | — |
| Central and Peripheral Nervous System - Abnormal CS (week 0) to abnormal CS (week 26) | — | 1 | — | — |
| Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26) | 117 | 117 | 114 | 115 |
| Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26) | 1 | 0 | 0 | 0 |
| Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26) | 2 | 0 | 0 | 0 |
| Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 | 3 | 2 | 5 |
| Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to normal (week 26) | — | 0 | — | 0 |
| Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal NCS (week 26) | — | 0 | — | 0 |
| Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal CS (week 26) | — | 2 | — | 1 |
| General Appearance - Normal (week 0) to normal (week 26) | 115 | 118 | 110 | 119 |
| General Appearance - Normal (week 0) to abnormal NCS (week 26) | 1 | 0 | 0 | 0 |
| General Appearance - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| General Appearance - Abnormal NCS (week 0) to normal (week 26) | 4 | 2 | 1 | 0 |
| General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26) | 0 | 2 | 4 | 1 |
| General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| General Appearance - Abnormal CS (week 0) to normal (week 26) | 0 | — | 0 | 0 |
| General Appearance - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | — | 0 | 0 |
| General Appearance - Abnormal CS (week 0) to abnormal CS (week 26) | 1 | — | 1 | 1 |
| Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26) | 121 | 118 | 115 | 117 |
| Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 1 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to normal (week 26) | — | 0 | — | 1 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal NCS (week 26) | — | 1 | — | 1 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal CS (week 26) | — | 0 | — | 0 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to normal (week 26) | — | 0 | 0 | 0 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal NCS (week 26) | — | 0 | 0 | 0 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal CS (week 26) | — | 3 | 1 | 1 |
| Lymph Node Palpation - Normal (week 0) to normal (week 26) | 120 | 121 | 115 | 119 |
| Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26) | 1 | 1 | 1 | 2 |
| Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Musculoskeletal System - Normal (week 0) to normal (week 26) | 119 | 119 | 115 | 119 |
| Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26) | 1 | 0 | 0 | 0 |
| Musculoskeletal System - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 1 |
| Musculoskeletal System - Abnormal NCS (week 0) to normal (week 26) | 0 | 0 | 0 | — |
| Musculoskeletal System - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 | 1 | 1 | — |
| Musculoskeletal System - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | — |
| Musculoskeletal System - Abnormal CS (week 0) to normal (week 26) | — | 1 | — | 0 |
| Musculoskeletal System - Abnormal CS (week 0) to abnormal NCS (week 26) | — | 0 | — | 0 |
| Musculoskeletal System - Abnormal CS (week 0) to abnormal CS (week 26) | — | 1 | — | 1 |
| Respiratory System - Normal (week 0) to normal (week 26) | 121 | 122 | 116 | 121 |
| Respiratory System - Normal (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Respiratory System - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Skin - Normal (week 0) to normal (week 26) | 99 | 106 | 98 | 105 |
| Skin - Normal (week 0) to abnormal NCS (week 26) | 1 | 0 | 1 | 0 |
| Skin - Normal (week 0) to abnormal CS (week 26) | 1 | 0 | 0 | 0 |
| Skin - Abnormal NCS (week 0) to normal (week 26) | 2 | 0 | 3 | 3 |
| Skin - Abnormal NCS (week 0) to abnormal NCS (week 26) | 11 | 7 | 11 | 9 |
| Skin - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Skin - Abnormal CS (week 0) to normal (week 26) | 0 | 2 | 1 | 1 |
| Skin - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Skin - Abnormal CS (week 0) to abnormal CS (week 26) | 7 | 7 | 2 | 3 |
| Thyroid Gland - Normal (week 0) to normal (week 26) | 119 | 120 | 113 | 119 |
| Thyroid Gland - Normal (week 0) to abnormal NCS (week 26) | 0 | 0 | 0 | 0 |
| Thyroid Gland - Normal (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Thyroid Gland - Abnormal NCS (week 0) to normal (week 26) | 0 | 0 | 0 | 0 |
| Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 | 2 | 3 | 1 |
| Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | 0 | 0 | 0 |
| Thyroid Gland - Abnormal CS (week 0) to normal (week 26) | — | — | — | 0 |
| Thyroid Gland - Abnormal CS (week 0) to abnormal NCS (week 26) | — | — | — | 0 |
| Thyroid Gland - Abnormal CS (week 0) to abnormal CS (week 26) | — | — | — | 1 |
Change from baseline (week 0) in eye examination category at week 26 is presented. Eye examination shift in findings were categorized as normal, abnormal NCS and abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Left Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 73 | 77 | 83 | 75 |
| Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 6 | 5 | 5 | 5 |
| Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 2 | 4 | 2 | 5 |
| Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 10 | 2 | 1 | 2 |
| Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 15 | 19 | 15 | 18 |
| Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 4 | 2 | 1 | 0 |
| Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 2 | 4 | 4 | 7 |
| Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | 1 | 0 | 0 |
| Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 8 | 7 | 8 | 9 |
| Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 76 | 76 | 82 | 74 |
| Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 6 | 6 | 4 | 5 |
| Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 3 | 4 | 3 | 3 |
| Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 8 | 3 | 3 | 3 |
| Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 14 | 18 | 15 | 19 |
| Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 4 | 1 | 1 | 0 |
| Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 2 | 3 | 5 | 8 |
| Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | 1 | 1 | 0 |
| Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 7 | 9 | 5 | 9 |
An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
| Events | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | 251 | 292 | 231 | 212 |
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
| Episodes | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 0 | 0 | 0 | 0 |
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 0 | 0 | 0 | 0 |
Anti-semaglutide binding antibody levels measured anytime during post-baseline visits (week 0 to week 31) are presented. The outcome data are presented as percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.
| %B/T | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg |
|---|---|---|---|
| Anti-semaglutide Binding Antibody Levels | — | 2.1 | — |
Number of participants who had anti-semaglutide binding antibody levels anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participants-investigator contact, and death for participants who died before any of the above.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg |
|---|---|---|---|
| Number of Participants With Anti-semaglutide Binding Antibodies | 0 | 1 | 0 |
Number of participants who had anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg |
|---|---|---|---|
| Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 | 0 | 0 | 0 |
Collected over From week 0 to week 31. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Semaglutide 3 mg | 0/130 (0%) | 6/130 (4.6%) | 30/130 (23.1%) |
| Oral Semaglutide 7 mg | 0/130 (0%) | 10/130 (7.7%) | 47/130 (36.2%) |
| Oral Semaglutide 14 mg | 0/129 (0%) | 5/129 (3.9%) | 40/129 (31%) |
| Placebo | 0/131 (0%) | 2/131 (1.5%) | 16/131 (12.2%) |
| Event | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 1/130 | 3/130 | 1/129 | 0/131 |
| CholelithiasisHepatobiliary disorders | 0/130 | 2/130 | 1/129 | 0/131 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/130 | 0/130 | 1/129 | 0/131 |
| CataractEye disorders | 0/130 | 0/130 | 1/129 | 0/131 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/130 | 0/130 | 1/129 | 0/131 |
| Spinal osteoarthritisMusculoskeletal and connective tissue disorders | 0/130 | 0/130 | 1/129 | 0/131 |
| Angina unstableCardiac disorders | 1/130 | 0/130 | 0/129 | 0/131 |
| Atrial fibrillationCardiac disorders | 1/130 | 0/130 | 0/129 | 0/131 |
| Cholecystitis acuteHepatobiliary disorders | 0/130 | 1/130 | 0/129 | 0/131 |
| Dermal cystSkin and subcutaneous tissue disorders | 0/130 | 1/130 | 0/129 | 0/131 |
| Event | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo |
|---|---|---|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 2/130 | 6/130 | 14/129 | 0/131 |
| DiarrhoeaGastrointestinal disorders | 4/130 | 12/130 | 12/129 | 2/131 |
| Upper respiratory tract infectionInfections and infestations | 11/130 | 12/130 | 9/129 | 6/131 |
| Lipase increasedInvestigations | 7/130 | 11/130 | 4/129 | 0/131 |
| Abdominal distensionGastrointestinal disorders | 1/130 | 10/130 | 2/129 | 1/131 |
| NauseaGastrointestinal disorders | 6/130 | 4/130 | 8/129 | 2/131 |
| ConstipationGastrointestinal disorders | 1/130 | 7/130 | 3/129 | 0/131 |
| HyperlipidaemiaMetabolism and nutrition disorders | 4/130 | 3/130 | 1/129 | 7/131 |
Full analysis set included all randomized participants.
| Age, Continuous(Years) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 54 ± 11 | 52 ± 11 | 53 ± 10 | 51 ± 11 | 52 ± 11 |
| Sex: Female, Male(Participants) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 58 | 41 | 47 | 43 | 189 |
| Male | 72 | 89 | 83 | 88 | 332 |
| Ethnicity (NIH/OMB)(Participants) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 130 | 130 | 129 | 131 | 520 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo | Total |
|---|---|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Race — Asian | 97 | 97 | 97 | 98 | 389 |
| Race — White | 33 | 32 | 33 | 33 | 131 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
Ran from Oct 2019 to primary completion in Sep 2021, 23 months.
Results were first posted in Sep 2023, 1 year 11 months after primary completion.
Of 438 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's 23 months is above that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide