A Phase 3 interventional study of Oral semaglutide and Sitagliptin in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 93 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.
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 1,441 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 informed consent.
For Taiwan only: Male or female, age above or equal to 20 years at the time of signing 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.
Oral semaglutide tablets 3 mg and sitagliptin placebo tablets for 26 weeks
Drug: Oral semaglutide · Drug: Placebo (sitagliptin)
Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 4 weeks, after which the target dose of 7 mg is taken for 22 weeks
Drug: Oral semaglutide · Drug: Placebo (sitagliptin)
Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 8 weeks, after which the target dose of 14 mg is taken for 18 weeks
Drug: Oral semaglutide · Drug: Placebo (sitagliptin)
Sitagliptin tablets and oral semaglutide placebo tablets for 26 weeks
Drug: Sitagliptin · Drug: Placebo (oral semaglutide)
Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets
Placebo tablet to be taken first thing in the morning
Placebo tablet to be taken 30 minutes after oral semaglutide
Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)
Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and 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. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)
Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) 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 and 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 to week 26
Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile
Change from baseline 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 and 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 to week 26
Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)
Change from baseline in 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 and 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 to week 26
Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)
Number of participants who achieved HbA1c \<7.0% (53 mmol/mol) (ADA target) is presented in category "Yes" and participants who could not achieve HbA1C \<7.0 (53 mmol/mol) (ADA target) is presented in category "No". 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 and 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: At week 26
Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)
Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) 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 and 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: At week 26
Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)
Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) 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 and 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: At week 26
Time to Rescue Medication
Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation 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 randomisation 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 and 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 to week 31
Change From Baseline to Week 26 in Body Weight (Kilogram [kg])
Change in body weight from baseline to week 26 in kg 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 and 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 to week 26
Percentage Change From Baseline to Week 26 in Body Weight
Percentage change from baseline to week 26 in body weight 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 and 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 to week 26
Change From Baseline to Week 26 in Body Mass Index (BMI)
Change from baseline in BMI 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 and 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 to week 26
Change From Baseline to Week 26 in Waist Circumference
Change from baseline in waist circumference 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 and 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 to week 26
Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)
Change from baseline in total cholesterol (measured in mmol/L) 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: From baseline to week 26
Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Change from baseline in LDL cholesterol (measured in mmol/L) 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: From baseline to week 26
Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Change from baseline in VLDL cholesterol (measured in mmol/L) 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: From baseline to week 26
Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Change from baseline in HDL Cholesterol (measured in mmol/L) 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: From baseline to week 26
Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)
Change from baseline in triglycerides (measured in mmol/L) 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: From baseline to week 26
Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)
Change from baseline in free fatty acids (measured in mmol/L) 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: From baseline to week 26
Change From Baseline to Week 26 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). A positive change score indicates an improvement since baseline. 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 end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: From baseline to week 26
Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)
Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)
Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)
Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or 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 In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no)
Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Number of Treatment-emergent Adverse Events During Exposure to Trial Product
An adverse event (AE) was defined as 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. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 31
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product
Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 31
Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils
Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)
Change from baseline in Haematocrit at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)
Change from baseline in Haemoglobin at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)
Change from baseline in Leucocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)
Change from baseline in thrombocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)
Change from baseline in calcium (total) (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)
Change from baseline in potassium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)
Change from baseline in sodium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)
Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)
Change from baseline in Albumin (measured in grams per deciliter \[g/dL\]) 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)
Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Vital Signs: Pulse Rate
Change from baseline in pulse rate 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure
Change from baseline in systolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure
Change from baseline in diastolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Change From Baseline to Week 26 in Electrocardiogram (ECG) Category
Change from baseline 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Physical Examination Category
The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: Baseline and week 26
Change From Baseline to Week 26 in Eye Examination Category
The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product
Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 31
The trial was conducted at 90 sites in 8 countries as follows: Brazil (3 sites), China (58 sites), Czech Republic (4 sites); Hong Kong (1 site), Romania (6 sites), Serbia (7 sites), Taiwan (4 sites), and South Africa (7 sites).
| Milestone | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Started | 361 | 360 | 361 | 359 |
| Full analysis set | 361 | 360 | 361 | 359 |
| Safety analysis set | 361 | 358 | 361 | 358 |
| Completed | 345 | 342 | 335 | 350 |
| Not completed | 16 | 18 | 26 | 9 |
| Withdrew: Withdrawal by subject | 13 | 12 | 21 | 7 |
| Withdrew: Lost to follow-up | 0 | 3 | 3 | 1 |
| Withdrew: Physician decision | 1 | 1 | 1 | 1 |
| Withdrew: Death | 2 | 2 | 1 | 0 |
Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and 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. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication.
| Percentage point of HbA1C | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| On-treatment observation period | -0.8 ± 1.0 | -1.3 ± 1.0 | -1.6 ± 1.0 | -0.7 ± 1.0 |
| In-trial observation period | -0.8 ± 1.0 | -1.3 ± 1.0 | -1.5 ± 1.0 | -0.7 ± 1.0 |
Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) 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 and 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.
| mmol/l | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | -1.03 ± 2.11 | -1.79 ± 2.20 | -2.00 ± 2.42 | -0.52 ± 2.36 |
Change from baseline 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 and 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.
| mmol/L | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -1.5 ± 2.2 | -2.3 ± 2.2 | -2.6 ± 2.2 | -1.2 ± 2.4 |
Change from baseline in 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 and 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.
| mmol/L | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | -0.4 ± 2.0 | -0.9 ± 1.9 | -1.0 ± 2.1 | -0.6 ± 2.1 |
Number of participants who achieved HbA1c \<7.0% (53 mmol/mol) (ADA target) is presented in category "Yes" and participants who could not achieve HbA1C \<7.0 (53 mmol/mol) (ADA target) is presented in category "No". 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 and 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 139 | 213 | 226 | 122 |
| No | 182 | 102 | 72 | 212 |
Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) 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 and 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 81 | 161 | 188 | 54 |
| No | 240 | 154 | 110 | 280 |
Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) 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 and 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 141 | 203 | 226 | 129 |
| No | 180 | 111 | 72 | 205 |
Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation 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 randomisation 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 and 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Time to Rescue Medication | 5 | 6 | 6 | 7 |
Change in body weight from baseline to week 26 in kg 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 and 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.
| Kilogram | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Body Weight (Kilogram [kg]) | -1.4 ± 3.0 | -2.9 ± 3.3 | -3.8 ± 3.7 | -0.5 ± 2.6 |
Percentage change from baseline to week 26 in body weight 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 and 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Percentage Change From Baseline to Week 26 in Body Weight | -2 ± 4 | -4 ± 4 | -5 ± 5 | -1 ± 3 |
Change from baseline in BMI 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 and 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.
| Kilogram per square meter (kg/m^2) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Body Mass Index (BMI) | -0.5 ± 1.1 | -1.1 ± 1.2 | -1.4 ± 1.3 | -0.2 ± 0.9 |
Change from baseline in waist circumference 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 and 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.
| Centimeter | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Waist Circumference | -1.6 ± 4.0 | -2.7 ± 4.4 | -3.7 ± 4.1 | -0.8 ± 3.4 |
Change from baseline in total cholesterol (measured in mmol/L) 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 1.00 ± 15.78 | 0.96 ± 17.34 | 0.96 ± 17.86 | 0.99 ± 19.69 |
Change from baseline in LDL cholesterol (measured in mmol/L) 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.02 ± 25.63 | 0.98 ± 28.70 | 0.98 ± 28.95 | 1.01 ± 30.12 |
Change from baseline in VLDL cholesterol (measured in mmol/L) 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 VLDL cholesterol | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | 1.05 ± 0.45 | 0.94 ± 0.37 | 0.94 ± 0.41 | 0.98 ± 0.43 |
Change from baseline in HDL Cholesterol (measured in mmol/L) 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.02 ± 13.25 | 1.01 ± 14.42 | 1.00 ± 14.82 | 1.00 ± 16.03 |
Change from baseline in triglycerides (measured in mmol/L) 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 | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.96 ± 43.41 | 0.86 ± 46.28 | 0.86 ± 46.40 | 0.91 ± 44.29 |
Change from baseline in free fatty acids (measured in mmol/L) 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 free fatty acids | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline) | 0.95 ± 56.36 | 0.89 ± 56.46 | 0.87 ± 66.18 | 0.96 ± 62.50 |
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). A positive change score indicates an improvement since baseline. 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 end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication.
| Score on a scale | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Physical Function | 0.20 ± 5.63 | 0.48 ± 3.95 | 0.93 ± 4.51 | 0.31 ± 5.25 |
| Role Physical | -0.47 ± 6.72 | -0.41 ± 6.82 | 0.28 ± 6.11 | 0.24 ± 7.27 |
| Bodily Pain | -0.06 ± 8.44 | -0.37 ± 8.08 | 0.51 ± 8.03 | 0.22 ± 8.44 |
| General Health | 1.47 ± 7.54 | 1.04 ± 7.09 | 1.95 ± 7.44 | 0.95 ± 7.19 |
| Vitality | 0.44 ± 6.68 | 0.84 ± 6.64 | 1.21 ± 7.66 | 0.33 ± 7.28 |
| Social Function | 0.49 ± 6.14 | -0.36 ± 6.45 | 0.17 ± 5.92 | 0.10 ± 6.36 |
| Role Emotional | 0.06 ± 8.80 | -0.66 ± 8.37 | 0.23 ± 8.26 | 0.03 ± 8.40 |
| Mental Health | 0.51 ± 7.01 | 0.33 ± 6.71 | 0.70 ± 7.34 | -0.7 ± 7.13 |
| Physical Component | 0.15 ± 5.32 | 0.29 ± 4.74 | 0.98 ± 5.00 | 0.69 ± 5.62 |
| Mental Component | 0.50 ± 6.71 | -0.07 ± 6.50 | 0.44 ± 6.75 | -0.39 ± 6.64 |
Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 109 | 175 | 199 | 68 |
| No | 234 | 164 | 133 | 282 |
Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 55 | 107 | 149 | 28 |
| No | 288 | 235 | 184 | 323 |
Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 5 | 24 | 42 | 2 |
| No | 338 | 318 | 291 | 349 |
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 In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 114 | 195 | 222 | 79 |
| No | 230 | 144 | 110 | 271 |
Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Yes | 64 | 128 | 159 | 33 |
| No | 280 | 211 | 173 | 317 |
An adverse event (AE) was defined as 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. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Events | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Number of Treatment-emergent Adverse Events During Exposure to Trial Product | 635 | 741 | 793 | 643 |
Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Episodes | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 | 2 | 2 | 1 |
Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| 10^9 cells per liter | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Basophils | 0.01 ± 0.05 | 0.01 ± 0.05 | 0.00 ± 0.04 | 0.00 ± 0.05 |
| Eosinophils | 0.00 ± 0.11 | 0.00 ± 0.09 | -0.01 ± 0.25 | -0.00 ± 0.11 |
| Lymphocytes | -0.03 ± 0.46 | 0.01 ± 0.40 | 0.00 ± 0.52 | 0.00 ± 0.39 |
| Monocytes | 0.01 ± 0.15 | 0.01 ± 0.13 | 0.01 ± 0.14 | 0.02 ± 0.12 |
| Neutrophils | 0.03 ± 1.08 | 0.13 ± 1.15 | 0.10 ± 1.22 | 0.31 ± 1.17 |
Change from baseline in Haematocrit at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of haematocrit | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline) | 1.01 ± 6.76 | 1.00 ± 6.64 | 1.00 ± 6.21 | 1.00 ± 6.35 |
Change from baseline in Haemoglobin at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of haemoglobin | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline) | 1.00 ± 5.71 | 1.00 ± 6.04 | 1.00 ± 5.47 | 1.00 ± 6.11 |
Change from baseline in Leucocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of leucocytes | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline) | 1.01 ± 19.28 | 1.02 ± 19.54 | 1.01 ± 21.24 | 1.04 ± 17.87 |
Change from baseline in thrombocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of thrombocytes | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline) | 0.99 ± 14.53 | 0.99 ± 16.65 | 0.99 ± 16.65 | 0.97 ± 15.65 |
Change from baseline in calcium (total) (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of calcium | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline) | 0.98 ± 4.40 | 0.98 ± 4.74 | 0.99 ± 4.80 | 0.98 ± 4.40 |
Change from baseline in potassium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of potassium | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline) | 1.00 ± 8.51 | 1.00 ± 8.34 | 1.00 ± 8.96 | 1.01 ± 9.28 |
Change from baseline in sodium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of sodium | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline) | 1.00 ± 1.58 | 1.00 ± 1.40 | 1.00 ± 1.49 | 1.00 ± 1.59 |
Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of urea | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline) | 1.00 ± 26.29 | 0.99 ± 25.61 | 0.98 ± 23.78 | 1.03 ± 22.67 |
Change from baseline in Albumin (measured in grams per deciliter \[g/dL\]) 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of albumin | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline) | 0.99 ± 4.40 | 0.99 ± 4.57 | 0.99 ± 5.22 | 0.99 ± 5.05 |
Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Ratio of calcitonin | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline) | 1.00 ± 38.33 | 1.05 ± 35.56 | 1.02 ± 36.49 | 1.01 ± 31.96 |
Change from baseline in pulse rate 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Beats per minute (beats/min) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Vital Signs: Pulse Rate | 78 ± 10 | 78 ± 11 | 78 ± 10 | 78 ± 10 |
Change from baseline in systolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Millimeter of mercury (mmHg) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure | 131 ± 16 | 132 ± 15 | 130 ± 14 | 130 ± 14 |
Change from baseline in diastolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Millimeter of mercury (mmHg) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure | 83 ± 10 | 84 ± 9 | 83 ± 10 | 83 ± 9 |
Change from baseline 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Normal (Baseline) to normal (week 26) | 174 | 163 | 165 | 175 |
| Normal (Baseline) to abnormal NCS (week 26) | 21 | 30 | 29 | 17 |
| Normal (Baseline) to abnormal CS (week 26) | 8 | 3 | 10 | 5 |
| Abnormal NCS (Baseline) to normal (week 26) | 26 | 27 | 26 | 43 |
| Abnormal NCS (Baseline) to abnormal NCS (week 26) | 56 | 61 | 40 | 64 |
| Abnormal NCS (Baseline) to abnormal CS (week 26) | 3 | 3 | 5 | 2 |
| Abnormal CS (Baseline) to normal (week 26) | 8 | 13 | 7 | 6 |
| Abnormal CS (Baseline) to abnormal NCS (week 26) | 5 | 3 | 4 | 9 |
| Abnormal CS (Baseline) to abnormal CS (week 26) | 27 | 25 | 17 | 23 |
The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Cardiovascular system - Normal (Baseline) | 354 | 353 | 355 | 356 |
| Cardiovascular system - abnormal NCS (Baseline) | 5 | 4 | 6 | 2 |
| Cardiovascular system - Abnormal CS (Baseline) | 2 | 1 | 0 | 0 |
| Cardiovascular system -Normal (Week 26) | 319 | 322 | 301 | 339 |
| Cardiovascular system - Abnormal NCS (Week 26) | 5 | 2 | 3 | 2 |
| Cardiovascular system - Abnormal CS (Week 26) | 3 | 2 | 1 | 0 |
| Central and Peripheral Nervous System - Normal (Baseline) | 355 | 351 | 358 | 357 |
| Central and Peripheral Nervous System - Abnormal NCS (Baseline) | 2 | 5 | 3 | 1 |
| Central and Peripheral Nervous System - Abnormal CS (Baseline) | 4 | 2 | 0 | 0 |
| Central and Peripheral Nervous System - Normal (Week 26) | 322 | 321 | 302 | 339 |
| Central and Peripheral Nervous System - Abnormal NCS (Week 26) | 2 | 3 | 2 | 2 |
| Central and Peripheral Nervous System - Abnormal CS (Week 26) | 2 | 2 | 1 | 0 |
| Gastrointestinal System incl. Mouth - Normal (Baseline) | 350 | 343 | 353 | 346 |
| Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline) | 10 | 14 | 7 | 11 |
| Gastrointestinal System incl. Mouth - Abnormal CS (Baseline) | 1 | 1 | 1 | 1 |
| Gastrointestinal System incl. Mouth - Normal (Week 26) | 314 | 315 | 300 | 329 |
| Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26) | 12 | 10 | 4 | 10 |
| Gastrointestinal System incl. Mouth - Abnormal CS (Week 26) | 0 | 1 | 1 | 2 |
| General Appearance - Normal (Baseline) | 329 | 325 | 328 | 328 |
| General Appearance - Abnormal NCS (Baseline) | 25 | 27 | 21 | 22 |
| General Appearance - Abnormal CS (Baseline) | 7 | 6 | 12 | 8 |
| General Appearance - Normal (Week 26) | 300 | 295 | 280 | 313 |
| General Appearance - Abnormal NCS (Week 26) | 21 | 27 | 19 | 21 |
| General Appearance - Abnormal CS (Week 26) | 6 | 4 | 6 | 7 |
| Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline) | 348 | 349 | 351 | 344 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline) | 9 | 8 | 5 | 6 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline) | 4 | 0 | 4 | 5 |
| Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26) | 322 | 319 | 297 | 330 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26) | 3 | 5 | 4 | 4 |
| Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26) | 2 | 1 | 2 | 5 |
| Lymph Node Palpation - Normal (Baseline) | 361 | 353 | 357 | 357 |
| Lymph Node Palpation - Abnormal NCS (Baseline) | 0 | 5 | 3 | 1 |
| Lymph Node Palpation - Abnormal CS (Baseline) | 0 | 0 | 1 | 0 |
| Lymph Node Palpation - Normal (Week 26) | 325 | 323 | 304 | 341 |
| Lymph Node Palpation - Abnormal NCS (Week 26) | 1 | 3 | 1 | 0 |
| Lymph Node Palpation - Abnormal CS (Week 26) | 0 | 0 | 0 | 0 |
| Musculoskeletal System - Normal (Baseline) | 344 | 345 | 351 | 352 |
| Musculoskeletal System - Abnormal NCS (Baseline) | 13 | 8 | 7 | 4 |
| Musculoskeletal System - Abnormal CS (Baseline) | 4 | 5 | 3 | 2 |
| Musculoskeletal System - Normal (Week 26) | 314 | 319 | 301 | 335 |
| Musculoskeletal System - Abnormal NCS (Week 26) | 6 | 4 | 2 | 3 |
| Musculoskeletal System - Abnormal CS (Week 26) | 6 | 3 | 2 | 3 |
| Respiratory System - Normal (Baseline) | 355 | 355 | 359 | 357 |
| Respiratory System -Abnormal NCS (Baseline) | 3 | 3 | 1 | 1 |
| Respiratory System - Abnormal CS (Baseline) | 3 | 0 | 1 | 0 |
| Respiratory System - Normal (Week 26) | 324 | 325 | 305 | 341 |
| Respiratory System - Abnormal NCS (Week 26) | 2 | 1 | 0 | 0 |
| Respiratory System - Abnormal CS (Week 26) | 0 | 0 | 0 | 0 |
| Skin - Normal (Baseline) | 282 | 282 | 296 | 277 |
| Skin - Abnormal NCS (Baseline) | 71 | 65 | 54 | 65 |
| Skin - Abnormal CS (Baseline) | 8 | 11 | 11 | 16 |
| Skin - Normal (Week 26) | 260 | 263 | 256 | 267 |
| Skin - Abnormal NCS (Week 26) | 60 | 52 | 42 | 60 |
| Skin - Abnormal CS (Week 26) | 7 | 11 | 7 | 14 |
| Thyroid Gland - Normal (Baseline) | 356 | 351 | 358 | 350 |
| Thyroid Gland - Abnormal NCS (Baseline) | 4 | 4 | 1 | 4 |
| Thyroid Gland - Abnormal CS (Baseline) | 1 | 3 | 2 | 4 |
| Thyroid Gland - Normal (Week 26) | 322 | 319 | 304 | 337 |
| Thyroid Gland - Abnormal NCS (Week 26) | 3 | 4 | 0 | 2 |
| Thyroid Gland - Abnormal CS (Week 26) | 2 | 3 | 1 | 2 |
The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Left Eye Ophthalmoscopy - Normal (Baseline) | 245 | 240 | 254 | 248 |
| Left Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 60 | 51 | 61 | 52 |
| Left Eye Ophthalmoscopy - Abnormal CS (Baseline) | 56 | 67 | 46 | 58 |
| Left Eye Ophthalmoscopy - Normal (Week 26) | 221 | 226 | 217 | 240 |
| Left Eye Ophthalmoscopy -Abnormal NCS (Week 26) | 49 | 44 | 50 | 39 |
| Left Eye Ophthalmoscopy - Abnormal CS (Week 26) | 55 | 53 | 34 | 56 |
| Right Eye Ophthalmoscopy - Normal (Baseline) | 240 | 234 | 257 | 240 |
| Right Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 64 | 54 | 56 | 53 |
| Right Eye Ophthalmoscopy - Abnormal CS (Baseline) | 57 | 69 | 48 | 65 |
| Right Eye Ophthalmoscopy - Normal (Week 26) | 223 | 218 | 220 | 233 |
| Right Eye Ophthalmoscopy - Abnormal NCS (Week 26) | 49 | 49 | 45 | 43 |
| Right Eye Ophthalmoscopy - Abnormal CS (Week 26) | 53 | 55 | 36 | 59 |
Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
| Participants | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 | 2 | 2 | 1 |
Collected over From baseline to week 31. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Semaglutide 3 mg | 2/361 (0.6%) | 16/361 (4.4%) | 109/361 (30.2%) |
| Oral Semaglutide 7 mg | 2/358 (0.6%) | 11/358 (3.1%) | 117/358 (32.7%) |
| Oral Semaglutide 14 mg | 1/361 (0.3%) | 11/361 (3%) | 144/361 (39.9%) |
| Sitagliptin 100 mg | 0/358 (0%) | 15/358 (4.2%) | 65/358 (18.2%) |
| Event | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 1/361 | 1/358 | 0/361 | 2/358 |
| Coronary artery diseaseCardiac disorders | 0/361 | 1/358 | 0/361 | 2/358 |
| UreterolithiasisRenal and urinary disorders | 1/361 | 2/358 | 0/361 | 0/358 |
| COVID-19Infections and infestations | 2/361 | 0/358 | 1/361 | 0/358 |
| Cerebral infarctionNervous system disorders | 0/361 | 0/358 | 2/361 | 0/358 |
| Acute myocardial infarctionCardiac disorders | 0/361 | 1/358 | 0/361 | 0/358 |
| AstheniaGeneral disorders | 0/361 | 0/358 | 0/361 | 1/358 |
| Cerebrovascular insufficiencyNervous system disorders | 0/361 | 0/358 | 0/361 | 1/358 |
| Chest painGeneral disorders | 0/361 | 1/358 | 1/361 | 0/358 |
| Colon adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/361 | 0/358 | 0/361 | 1/358 |
| Event | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 30/361 | 32/358 | 48/361 | 16/358 |
| NauseaGastrointestinal disorders | 36/361 | 39/358 | 44/361 | 14/358 |
| Decreased appetiteMetabolism and nutrition disorders | 22/361 | 30/358 | 34/361 | 5/358 |
| Upper respiratory tract infectionInfections and infestations | 26/361 | 25/358 | 31/361 | 28/358 |
| VomitingGastrointestinal disorders | 16/361 | 18/358 | 29/361 | 1/358 |
| Lipase increasedInvestigations | 15/361 | 17/358 | 21/361 | 12/358 |
Full analysis set (FAS) included all randomized participants.
| Age, Continuous(Years) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg | Total |
|---|---|---|---|---|---|
| Mean | 53.5 ± 11.2 | 53.4 ± 10.8 | 53.5 ± 10.5 | 52.9 ± 10.9 | 53.3 ± 10.8 |
| Sex: Female, Male(Participants) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg | Total |
|---|---|---|---|---|---|
| Female | 152 | 147 | 146 | 156 | 601 |
| Male | 209 | 213 | 215 | 203 | 840 |
| Ethnicity (NIH/OMB)(Participants) | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 17 | 19 | 15 | 18 | 69 |
| Not Hispanic or Latino | 344 | 341 | 346 | 341 | 1372 |
| 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 | Sitagliptin 100 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 272 | 270 | 271 | 271 | 1084 |
| Black or African American | 8 | 14 | 5 | 11 | 38 |
| NA | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Other | 8 | 11 | 18 | 18 | 55 |
| White | 73 | 65 | 67 | 59 | 264 |
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Studies of the drug tested here: Semaglutide