A Phase 3 interventional study of Oral semaglutide and Placebo (semaglutide) in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 97 sites in 22 countries. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.
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 132 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.
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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.
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.
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.
Participants will receive semaglutide tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.
Drug: Oral semaglutide
Participants will receive semaglutide placebo tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.
Drug: Placebo (semaglutide)
Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
Placebo treatment for 52 weeks.
Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point
This outcome measure reports change from baseline to week 26 in HbA1c measured in terms of percentage point.
Time frame: Baseline (Week 0), Week 26
Change From Baseline (Week 0) in HbA1c to Week 26- Millimoles Per Mole (mmol/Mol)
This outcome measure reports change from baseline to week 26 in HbA1c in terms of mmol/mol.
Time frame: Baseline (Week 0), Week 26
Change From Baseline (Week 0) in Fasting Plasma Glucose (FPG) to Week 26
This outcome measure reports change from baseline in FPG to week 26 measured in terms of milligrams per deciliter (mg/dL).
Time frame: Baseline (Week 0), Week 26
Change From Baseline (Week 0) in Body Mass Index (BMI) Standard Deviation Score (SDS) to Week 26
This outcome measure reports change from baseline to week 26 in BMI measured in terms of the SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The BMI SDS formula comes from the LMS method as: Z = (\[BMI/M)\]\^L-1)/ L×S where: L=Skewness (Box-Cox power); M=Median; S= (Coefficient of Variation).
Time frame: Baseline (Week 0), Week 26
Change From Baseline in HbA1c at Week 52 (Percentage Point)
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of percentage point.
Time frame: Baseline (Week 0), Week 52
Change From Baseline in HbA1c at Week 52 (mmol/Mol)
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of mmol/mol.
Time frame: Baseline (Week 0), Week 52
Change From Baseline in Fasting Plasma Glucose at Week 52 (mg/dL)
This outcome measure reports change from baseline to week 52 in FPG measured in terms of mg/dL.
Time frame: Baseline (Week 0), Week 52
Change From Baseline in Body Weight to Week 26 and Week 52 (Kilograms [kg])
This outcome measure reports change from baseline to week 26 and week 52 in body weight measured in terms of kg.
Time frame: Baseline (Week 0), Week 26, Week 52
Relative Change From Baseline in Body Weight to Week 26 and Week 52
This outcome measure reports relative change from baseline to week 26 and week 52 in body weight measured in terms of percent change.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline in Waist Circumference to Week 26 and Week 52
This outcome measure reports change from baseline to week 26 and week 52 in Waist circumference measured in terms of centimeters (cm).
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline in Body Mass Index Standard Deviation Score at Week 52
This outcome measure reports change from baseline to week 52 in BMI measured in terms of SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The BMI SDS formula comes from the LMS method: Z = (\[BMI/M)\]\^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation)
Time frame: Baseline (Week 0), Week 52
Change From Baseline (Week 0) in BMI Percentile (Age and Gender Adjusted) to Week 26 and Week 52
This outcome measure reports change from baseline (Week 0) in BMI percentile on gender and age-specific growth charts change in terms of percentile of BMI to week 26 and week 52. BMI Percentile was calculated using the CDC 2000 Reference Growth Charts and was derived using the standard LMS method. The CDC reference-specific parameters - L (Lambda), M (Median) and S (Coefficient of Variation) were extracted from the CDC reference tables based on each subject's age (in months) and sex. These parameters were used to compute BMI Z-scores, which were subsequently converted to percentiles using the standard normal distribution function.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline in Body Mass Index at Week 26 and Week 52
This outcome measure reports change from baseline to week 52 in BMI measured in terms of Kilograms per meter square (kg/m\^2).
Time frame: Baseline (Week 0), Week 26, Week 52
Percent Change From Baseline in Body Mass Index at Week 26 and Week 52
This outcome measure reports percent change from baseline to week 26 and week 52 in BMI measured in terms of percent change.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Body Mass Index Percentage of the 95th Percentile to Week 26 and to Week 52
This outcome measure reports change from baseline (week 0) in BMI percentage of the 95th percentile in terms of percentage point to week 26 and week 52. BMI Percentage of the 95th Percentile was calculated using the CDC 2000 Reference Growth Charts and was calculated as the ratio of the subject's observed BMI to the CDC age-and-sex-specific 95th percentile BMI reference value, expressed as a percentage.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 26 and Week 52
This outcome measure reports change from baseline in systolic and diastolic blood pressure at week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Percentage of Participants With HbA1c Less Than (<) 7.0% (53 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)
This outcome measure reports percentage of participants with HbA1c \<7.0% at week 26 and week 52 in terms of Yes, No, and Missing.
Time frame: At Week 26 and Week 52
Percentage of Participants With HbA1c Less Than or Equals (≤) 6.5% (48 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)
This outcome measure reports percentage of participants with HbA1c \<6.5% (48 mmol/mol) at week 26 and week 52 in terms of Yes, No, and Missing.
Time frame: At Week 26 and Week 52
Number of Events With Initiation of Additional Anti-diabetic Medication
This outcome measure reports number of events with initiation of additional anti-diabetic medication . Anti-diabetic medication was defined as new anti-diabetic medication and/or intensification of anti-diabetic medication initiated at or after randomization and before (planned) end-of-treatment.
Time frame: At Week 52
Number of Events With Initiation of Rescue Medication
This outcome measure reports number of events with initiation of rescue medication. Rescue medication is defined as new anti-diabetic medication and/or intensification of antidiabetic medication initiated at or after randomization and before last date on trial product. This is a subset of the additional anti-diabetic medication.
Time frame: At Week 52
Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product for All Participants
This outcome measure reports number of TEAEs during exposure to trial product for all participants in each arm were assessed up to approximately 57 weeks. Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period.
Time frame: From Baseline (Week 0) to Week 57
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes From Randomization to Week 26 for All Participants
This outcome measure reports number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes from randomization to week 26. Data reflects the total number of episodes across all participants in each arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the International Society for Paediatric and Adolescent Diabetes (ISPAD) classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?
Time frame: From Baseline (Week 0) to Week 26
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes, Assessed for 57 Weeks
This outcome measure represented number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product, assessed up to approximately 57 weeks. Data reflects the total number of episodes across all participants in each Arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose).
Time frame: From Baseline (Week 0) to Week 57
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episode From Randomization to Week 26 (Yes/No)
This outcome measures report number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode from randomization to week 26. AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period.
Time frame: From Baseline (Week 0) to Week 26
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episode During Exposure to Trial Product, Assessed up to Approximately 57 Weeks (Yes/No)
This outcome measure reports number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product, assessed up to approximately 57 weeks. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?
Time frame: From Baseline (Week 0) to Week 57
Change From Baseline (Week 0) in Amylase to Week 26 and Week 52
This outcome measure reports change in amylase from baseline (week 0) to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Lipase to Week 26 and Week 52, Ratio to Baseline
This outcome measure reports change in lipase from baseline (week 0) to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Insulin-like Growth Factor 1 (IGF-1) to Week 26 and Week 52
This outcome measure reports change in IGF-1 from baseline (week 0) to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Insulin-Like Growth Factor Binding Protein 3 (IGFBP 3) Serum to Week 26 and Week 52
This outcome measure reports change in IGFBP 3 serum from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Calcitonin to Week 26 and Week 52
This outcome measure reports change in calcitonin from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Estradiol (for Girls) to Week 26 and Week 52
This outcome measure reports change in estradiol from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Testosterone (for Boys) to Week 26 and Week 52
This outcome measure reports change in testosterone (for boys) from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Prolactin to Week 26 and Week 52
This outcome measure reports change in prolactin from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Thyroid Stimulating Hormone (TSH/Thyrotropin) to Week 26 and Week 52
This outcome measure reports change in TSH/thyrotropin from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Follicle Stimulating Hormone (FSH) to Week 26 and Week 52
This outcome measure reports change in FSH from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Luteinizing Hormone (LH) to Week 26 and Week 52
This outcome measure reports change in LH from baseline to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Dehydroepiandrosterone Sulfate (DHEAS) to Week 26 and Week 52
This outcome measure reports change from baseline to week 26 and week 52 in DHEAS.
Time frame: Baseline (Week 0), Week 26, Week 52
Anti-semaglutide Antibody Status (Positive/Negative/Missing)
This outcome measure reports anti-semaglutide antibody status as positive, negative, and missing on week 0, week 26, week 52, and week 57.
Time frame: Week 0, week 26, week 52, and week 57
Anti-semaglutide Antibody Titer
This outcome measure was to report anti-semaglutide antibody titer. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titers at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
Time frame: From Week 0 to Week 57
Anti-semaglutide Antibodies With in Vitro Neutralising Effect to Semaglutide
This outcome measure as to report anti-semaglutide antibodies with in vitro neutralising effect to semaglutide from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
Time frame: From Week 0 to Week 57
Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Positive/Negative)
This outcome measure reports anti-semaglutide antibodies cross reacting with endogenous GLP-1 status as positive and negative. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
Time frame: From Week 0 to Week 57
Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1
This outcome measure reports number of participants with cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1 from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
Time frame: From Week 0 to Week 57
Height Velocity at Week 26 and Week 52
This outcome measure reports height velocity at week 26 and week 52. The height velocity was calculated at week 26 and week 52. Height velocity at week 26 is the difference in height at week 26 and baseline, divided by the actual time elapsed in that period. Height velocity at week 52 is the difference in height at week 26, divided by the actual time elapsed in that period.
Time frame: At week 26 and week 52
Change From Baseline (Week 0) in Height SDS to Week 26 and Week 52
This outcome measure reports change from baseline in height SDS to week 26 and week 52. Height SDS described individual's height compares to the average height of a reference population of the same age and sex, where a score of 0 represents the population mean, negative values indicate shorter-than-average height, and positive values indicate taller-than-average height. Height SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The Height SDS formula comes from the LMS method: Z = (\[Height SDS/M)\]\^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation).
Time frame: Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Bone Age Assessment Through X-ray at Week 52
This outcome measure reports change from baseline (week 0) in bone age at week 52 where the assessment was done using X-ray. An X-ray of the left hand and wrist were performed at randomization and at the end of treatment visit for all participants for evaluation of bone age. The X-rays was analyzed by a central reader for determination of bone age.
Time frame: Baseline (Week 0), Week 52
Change From Baseline (Week 0) in Number of Participants With Pubertal Assessment (Tanner Staging) (Stage 1-5 Where 5 is Full Sexual Maturity) to Week 52
This outcome measure reports change from baseline (week 0) in number of participants with pubertal assessment which was assessed by the Tanner staging in accordance with the stages I-V (stage 1-5 where 5 is full sexual maturity) to week 52. Tanner stage is an overall stage which is the highest stage for girls: Breast development and Pubic hair development; and for boys: genital development and pubic hair development.
Time frame: Baseline (Week 0), Week 52
Change From Pre-dose to Post-dose (25 and 40 Minutes) in Lactate at Week 12 and Week 26
This outcome measure reports change from pre-dose to post-dose (25 and 40 minutes) in Lactate at week 12 and week 26.
Time frame: Pre-dose: Baseline (Week 0), Post-dose (25 mins and 40 mins): Week 12 and Week 26
Change From Baseline (Week 0) in Pulse Rate to Week 26 and Week 52
This outcome measure reports change from baseline (week 0) in pulse rate to week 26 and week 52.
Time frame: Baseline (Week 0), Week 26, and Week 52
Pharmacokinetic (PK): Apparent Clearance (CL/F)
This pharmacokinetic outcome reports CL/F at Week 26: Pre-dose (0 minute before glucose administration) and post dose at 25 and 40 minutes.
Time frame: Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
PK: Average Concentration (Cavg)
This pharmacokinetic outcome reports Cavg at Week 26.
Time frame: Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
PK: Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate (SNAC) Plasma Concentrations
This outcome measure reports SNAC plasma concentration at week 12 and week 26.
Time frame: Week 12 and Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
Trial participants were randomized to treatment at 45 sites in 19 countries.
| Milestone | Oral Semaglutide | Placebo |
|---|---|---|
| Started | 66 | 66 |
| Full analysis set (fas) | 66 | 66 |
| Safety analysis set (sas) | 66 | 66 |
| Completed | 64 | 66 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
This outcome measure reports change from baseline to week 26 in HbA1c measured in terms of percentage point.
| Percentage point | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point | -1.0 ± 1.5 | -0.3 ± 1.3 |
This outcome measure reports change from baseline to week 26 in HbA1c in terms of mmol/mol.
| mmol/mol | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline (Week 0) in HbA1c to Week 26- Millimoles Per Mole (mmol/Mol) | -11.2 ± 16.5 | -2.8 ± 14.3 |
This outcome measure reports change from baseline in FPG to week 26 measured in terms of milligrams per deciliter (mg/dL).
| mg/dL | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline (Week 0) in Fasting Plasma Glucose (FPG) to Week 26 | -28.2 ± 49.1 | -8.1 ± 65.1 |
This outcome measure reports change from baseline to week 26 in BMI measured in terms of the SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The BMI SDS formula comes from the LMS method as: Z = (\[BMI/M)\]\^L-1)/ L×S where: L=Skewness (Box-Cox power); M=Median; S= (Coefficient of Variation).
| standard deviation score | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline (Week 0) in Body Mass Index (BMI) Standard Deviation Score (SDS) to Week 26 | -0.1 ± 0.3 | -0.1 ± 0.3 |
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of percentage point.
| Percentage point | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline in HbA1c at Week 52 (Percentage Point) | -0.8 ± 1.4 | 0.2 ± 1.4 |
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of mmol/mol.
| mmol/mol | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline in HbA1c at Week 52 (mmol/Mol) | -9.0 ± 15.8 | 2.5 ± 14.8 |
This outcome measure reports change from baseline to week 52 in FPG measured in terms of mg/dL.
| mg/dL | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 52 (mg/dL) | -21.2 ± 54.8 | 2.2 ± 53.8 |
This outcome measure reports change from baseline to week 26 and week 52 in body weight measured in terms of kg.
| kg | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -1.3 ± 4.1 | -0.4 ± 5.7 |
| Week 52 | -0.7 ± 5.1 | 1.1 ± 5.8 |
This outcome measure reports relative change from baseline to week 26 and week 52 in body weight measured in terms of percent change.
| Percent change in body weight | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -1.55 ± 5.18 | 0.18 ± 4.85 |
| Week 52 | -0.94 ± 6.57 | 1.86 ± 5.54 |
This outcome measure reports change from baseline to week 26 and week 52 in Waist circumference measured in terms of centimeters (cm).
| cm | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -1.6 ± 5.7 | -1.6 ± 5.4 |
| Week 52 | -2.0 ± 5.9 | -0.4 ± 6.3 |
This outcome measure reports change from baseline to week 52 in BMI measured in terms of SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The BMI SDS formula comes from the LMS method: Z = (\[BMI/M)\]\^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation)
| Standard deviation score | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline in Body Mass Index Standard Deviation Score at Week 52 | -0.2 ± 0.4 | -0.0 ± 0.3 |
This outcome measure reports change from baseline (Week 0) in BMI percentile on gender and age-specific growth charts change in terms of percentile of BMI to week 26 and week 52. BMI Percentile was calculated using the CDC 2000 Reference Growth Charts and was derived using the standard LMS method. The CDC reference-specific parameters - L (Lambda), M (Median) and S (Coefficient of Variation) were extracted from the CDC reference tables based on each subject's age (in months) and sex. These parameters were used to compute BMI Z-scores, which were subsequently converted to percentiles using the standard normal distribution function.
| Percentile of BMI | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -1.7 ± 7.6 | 0.2 ± 1.9 |
| Week 52 | -2.9 ± 10.4 | 0.5 ± 3.3 |
This outcome measure reports change from baseline to week 52 in BMI measured in terms of Kilograms per meter square (kg/m\^2).
| kg/m^2 | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -0.8 ± 1.6 | -0.5 ± 2.1 |
| Week 52 | -0.7 ± 2.0 | -0.1 ± 2.1 |
This outcome measure reports percent change from baseline to week 26 and week 52 in BMI measured in terms of percent change.
| Percent Change | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -2.49 ± 5.34 | -1.00 ± 4.92 |
| Week 52 | -2.47 ± 6.85 | 0.13 ± 5.59 |
This outcome measure reports change from baseline (week 0) in BMI percentage of the 95th percentile in terms of percentage point to week 26 and week 52. BMI Percentage of the 95th Percentile was calculated using the CDC 2000 Reference Growth Charts and was calculated as the ratio of the subject's observed BMI to the CDC age-and-sex-specific 95th percentile BMI reference value, expressed as a percentage.
| Percentage point of BMI | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -2.9 ± 5.9 | -1.9 ± 8.0 |
| Week 52 | -2.6 ± 7.4 | -0.4 ± 8.1 |
This outcome measure reports change from baseline in systolic and diastolic blood pressure at week 26 and week 52.
| Millimeters of mercury (mmHg) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26: Systolic blood pressure | -2.4 ± 9.3 | 0.3 ± 10.4 |
| Week 26: Diastolic blood pressure | -0.5 ± 9.2 | 0.0 ± 9.9 |
| Week 52: Systolic blood pressure | -2.8 ± 8.5 | 1.6 ± 8.8 |
| Week 52: Diastolic blood pressure | -2.3 ± 8.3 | -0.6 ± 9.6 |
This outcome measure reports percentage of participants with HbA1c \<7.0% at week 26 and week 52 in terms of Yes, No, and Missing.
| Percentage of participants | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26: Yes | 62.12 | 28.79 |
| Week 26: No | 37.88 | 65.15 |
| Week 26: Missing | 0 | 6.06 |
| Week 52: Yes | 57.58 | 16.67 |
| Week 52: No | 36.36 | 80.30 |
| Week 52: Missing | 6.06 | 3.03 |
This outcome measure reports percentage of participants with HbA1c \<6.5% (48 mmol/mol) at week 26 and week 52 in terms of Yes, No, and Missing.
| Percentage of participants | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26: Yes | 50.0 | 16.67 |
| Week 26: No | 50.0 | 77.27 |
| Week 26: Missing | 0 | 6.06 |
| Week 52: Yes | 46.97 | 10.61 |
| Week 52: No | 46.97 | 86.36 |
| Week 52: Missing | 6.06 | 3.03 |
This outcome measure reports number of events with initiation of additional anti-diabetic medication . Anti-diabetic medication was defined as new anti-diabetic medication and/or intensification of anti-diabetic medication initiated at or after randomization and before (planned) end-of-treatment.
| Events | Oral Semaglutide | Placebo |
|---|---|---|
| Number of Events With Initiation of Additional Anti-diabetic Medication | 9 | 18 |
This outcome measure reports number of events with initiation of rescue medication. Rescue medication is defined as new anti-diabetic medication and/or intensification of antidiabetic medication initiated at or after randomization and before last date on trial product. This is a subset of the additional anti-diabetic medication.
| Events | Oral Semaglutide | Placebo |
|---|---|---|
| Number of Events With Initiation of Rescue Medication | 6 | 17 |
This outcome measure reports number of TEAEs during exposure to trial product for all participants in each arm were assessed up to approximately 57 weeks. Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period.
| Events | Oral Semaglutide | Placebo |
|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product for All Participants | 309 | 254 |
This outcome measure reports number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes from randomization to week 26. Data reflects the total number of episodes across all participants in each arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the International Society for Paediatric and Adolescent Diabetes (ISPAD) classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?
| episodes | Oral Semaglutide | Placebo |
|---|---|---|
| Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes From Randomization to Week 26 for All Participants | 3 | 6 |
This outcome measure represented number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product, assessed up to approximately 57 weeks. Data reflects the total number of episodes across all participants in each Arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose).
| Episodes | Oral Semaglutide | Placebo |
|---|---|---|
| Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes, Assessed for 57 Weeks | 3 | 13 |
This outcome measures report number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode from randomization to week 26. AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period.
| Participants | Oral Semaglutide | Placebo |
|---|---|---|
| Yes | 1 | 4 |
| No | 65 | 62 |
This outcome measure reports number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product, assessed up to approximately 57 weeks. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?
| Participants | Oral Semaglutide | Placebo |
|---|---|---|
| Yes | 1 | 6 |
| No | 65 | 60 |
This outcome measure reports change in amylase from baseline (week 0) to week 26 and week 52.
| Ratio to baseline in amylase | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 1.12 ± 0.42 | 1.11 ± 0.26 |
| Week 52 | 1.10 ± 0.28 | 1.03 ± 0.18 |
This outcome measure reports change in lipase from baseline (week 0) to week 26 and week 52.
| Ratio to baseline in lipase | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 1.28 ± 0.75 | 1.12 ± 0.33 |
| Week 52 | 1.23 ± 0.47 | 1.32 ± 1.09 |
This outcome measure reports change in IGF-1 from baseline (week 0) to week 26 and week 52.
| Nanograms per milliliter (ng/mL) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 13.1 ± 61.5 | -20.6 ± 67.8 |
| Week 52 | -17.3 ± 67.6 | -58.7 ± 68.6 |
This outcome measure reports change in IGFBP 3 serum from baseline to week 26 and week 52.
| Milligrams per liter (mg/L) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 0.0 ± 1.0 | 0.2 ± 1.2 |
| Week 52 | -0.2 ± 0.9 | -0.0 ± 0.9 |
This outcome measure reports change in calcitonin from baseline to week 26 and week 52.
| Picograms per milliliter (pg/mL) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 0.2 ± 1.7 | -0.1 ± 1.1 |
| Week 52 | 0.2 ± 1.2 | -0.1 ± 0.6 |
This outcome measure reports change in estradiol from baseline to week 26 and week 52.
| pg/mL | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -2.6 ± 73.3 | 8.2 ± 91.1 |
| Week 52 | 21.3 ± 67.3 | 36.3 ± 101.1 |
This outcome measure reports change in testosterone (for boys) from baseline to week 26 and week 52.
| Nanomole per Liter (nmol/L) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 2.5 ± 4.5 | 1.2 ± 2.8 |
| Week 52 | 2.4 ± 5.2 | 0.5 ± 2.8 |
This outcome measure reports change in prolactin from baseline to week 26 and week 52.
| Milli-international units/Liter(mIU/L) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 1.7 ± 123.4 | -4.5 ± 92.7 |
| Week 52 | 39.5 ± 141.6 | 15.0 ± 104.4 |
This outcome measure reports change in TSH/thyrotropin from baseline to week 26 and week 52.
| mIU/L | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | -0.2 ± 1.2 | -1.2 ± 5.4 |
| Week 52 | 0.1 ± 1.2 | -0.7 ± 5.0 |
This outcome measure reports change in FSH from baseline to week 26 and week 52.
| International units per Liter (IU/L) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 0.3 ± 2.2 | 0.2 ± 2.9 |
| Week 52 | 0.0 ± 1.8 | 0.1 ± 2.4 |
This outcome measure reports change in LH from baseline to week 26 and week 52.
| IU/L | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 0.4 ± 5.3 | -0.0 ± 7.0 |
| Week 52 | 0.8 ± 4.4 | 0.5 ± 6.8 |
This outcome measure reports change from baseline to week 26 and week 52 in DHEAS.
| Micromoles per liter (μmol/L) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 0.5 ± 1.5 | 0.5 ± 1.8 |
| Week 54 | 0.8 ± 2.4 | 0.7 ± 2.0 |
This outcome measure reports anti-semaglutide antibody status as positive, negative, and missing on week 0, week 26, week 52, and week 57.
| Participants | Oral Semaglutide | Placebo |
|---|---|---|
| Week 0: Positive | 0 | 0 |
| Week 0: Negative | 65 | 0 |
| Week 0: Missing | 1 | 0 |
| Week 26: Positive | 0 | 0 |
| Week 26: Negative | 66 | 0 |
| Week 26: Missing | 0 | 0 |
| Week 52: Positive | 0 | 0 |
| Week 52: Negative | 61 | 0 |
| Week 52: Missing | 5 | 0 |
| Week 57: Positive | 0 | 0 |
| Week 57: Negative | 58 | 0 |
| Week 57: Missing | 8 | 0 |
This outcome measure was to report anti-semaglutide antibody titer. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titers at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
No measurements were reported for this outcome.
This outcome measure as to report anti-semaglutide antibodies with in vitro neutralising effect to semaglutide from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
No measurements were reported for this outcome.
This outcome measure reports anti-semaglutide antibodies cross reacting with endogenous GLP-1 status as positive and negative. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
No measurements were reported for this outcome.
This outcome measure reports number of participants with cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1 from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
No measurements were reported for this outcome.
This outcome measure reports height velocity at week 26 and week 52. The height velocity was calculated at week 26 and week 52. Height velocity at week 26 is the difference in height at week 26 and baseline, divided by the actual time elapsed in that period. Height velocity at week 52 is the difference in height at week 26, divided by the actual time elapsed in that period.
| Centimeters per year (cm/year) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 1.5 ± 2.2 | 1.8 ± 2.1 |
| Week 52 | 1.0 ± 1.8 | 0.8 ± 1.7 |
This outcome measure reports change from baseline in height SDS to week 26 and week 52. Height SDS described individual's height compares to the average height of a reference population of the same age and sex, where a score of 0 represents the population mean, negative values indicate shorter-than-average height, and positive values indicate taller-than-average height. Height SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The Height SDS formula comes from the LMS method: Z = (\[Height SDS/M)\]\^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation).
| standard deviation score | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 0.1 ± 0.2 | 0.1 ± 0.2 |
| Week 52 | 0.2 ± 0.3 | 0.2 ± 0.2 |
This outcome measure reports change from baseline (week 0) in bone age at week 52 where the assessment was done using X-ray. An X-ray of the left hand and wrist were performed at randomization and at the end of treatment visit for all participants for evaluation of bone age. The X-rays was analyzed by a central reader for determination of bone age.
| years | Oral Semaglutide | Placebo |
|---|---|---|
| Change From Baseline (Week 0) in Bone Age Assessment Through X-ray at Week 52 | 0.8 ± 1.0 | 0.8 ± 1.0 |
This outcome measure reports change from baseline (week 0) in number of participants with pubertal assessment which was assessed by the Tanner staging in accordance with the stages I-V (stage 1-5 where 5 is full sexual maturity) to week 52. Tanner stage is an overall stage which is the highest stage for girls: Breast development and Pubic hair development; and for boys: genital development and pubic hair development.
| Participants | Tanner Stage 1 (Week 0) | Tanner Stage 2 (Week 0) | Tanner Stage 3 (Week 0) | Tanner Stage 4 (Week 0) | Tanner Stage 5 (Week 0) |
|---|---|---|---|---|---|
| Semaglutide: Stage 1 (Week 52) | 1 | 0 | 0 | 0 | 0 |
| Semaglutide: Stage 2 (Week 52) | 1 | 0 | 0 | 0 | 0 |
| Semaglutide: Stage 3 (Week 52) | 1 | 0 | 0 | 0 | 0 |
| Semaglutide: Stage 4 (Week 52) | 0 | 0 | 5 | 5 | 0 |
| Semaglutide: Stage 5 (Week 52) | 0 | 0 | 0 | 12 | 37 |
| Placebo: Stage 1 (Week 52) | 1 | 0 | 0 | 0 | 0 |
| Placebo: Stage 2 (Week 52) | 0 | 0 | 0 | 0 | 0 |
| Placebo: Stage 3 (Week 52) | 0 | 2 | 2 | 0 | 0 |
| Placebo: Stage 4 (Week 52) | 0 | 0 | 4 | 6 | 0 |
| Placebo: Stage 5 (Week 52) | 0 | 0 | 1 | 13 | 31 |
This outcome measure reports change from pre-dose to post-dose (25 and 40 minutes) in Lactate at week 12 and week 26.
| Millimoles per liter (mmol/L) | Oral Semaglutide | Placebo |
|---|---|---|
| Week 12: 25 mins (post dose) | -0.1 ± 0.6 | -0.1 ± 0.4 |
| Week 12: 40 mins (post dose) | -0.2 ± 0.6 | -0.1 ± 0.5 |
| Week 26: 25 mins (post dose) | -0.2 ± 0.5 | -0.1 ± 1.5 |
| Week 26: 40 mins (post dose) | -0.1 ± 0.7 | -0.3 ± 1.1 |
This outcome measure reports change from baseline (week 0) in pulse rate to week 26 and week 52.
| Beats/minute | Oral Semaglutide | Placebo |
|---|---|---|
| Week 26 | 0.7 ± 11.9 | -0.4 ± 9.9 |
| Week 52 | 1.8 ± 12.6 | 0.2 ± 9.8 |
This pharmacokinetic outcome reports CL/F at Week 26: Pre-dose (0 minute before glucose administration) and post dose at 25 and 40 minutes.
Results for this outcome have not been posted.
This pharmacokinetic outcome reports Cavg at Week 26.
Results for this outcome have not been posted.
This outcome measure reports SNAC plasma concentration at week 12 and week 26.
| Nanograms per milliliter | Oral Semaglutide |
|---|---|
| Week 12: 0 mins | 12.2 ± 34.7 |
| Week 12: 25 mins | 709.3 ± 777.0 |
| Week 12: 40 mins | 380.0 ± 323.1 |
| Week 26: 0 mins | 11.6 ± 52.1 |
| Week 26: 25 mins | 647.5 ± 540.0 |
| Week 26: 40 mins | 392.6 ± 285.9 |
Collected over From Baseline (Week 0) up to 57 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Semaglutide | 0/66 (0%) | 5/66 (7.6%) | 45/66 (68.2%) |
| Placebo | 0/66 (0%) | 2/66 (3%) | 40/66 (60.6%) |
| Event | Oral Semaglutide | Placebo |
|---|---|---|
| AggressionPsychiatric disorders | 1/66 | 0/66 |
| Anaphylactic reactionImmune system disorders | 1/66 | 0/66 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/66 | 0/66 |
| Cerebral venous sinus thrombosisNervous system disorders | 0/66 | 1/66 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 1/66 | 1/66 |
| GastroenteritisInfections and infestations | 1/66 | 0/66 |
| Mucocutaneous candidiasisInfections and infestations | 0/66 | 1/66 |
| ObesityMetabolism and nutrition disorders | 0/66 | 1/66 |
| PneumoniaInfections and infestations | 0/66 | 1/66 |
| Event | Oral Semaglutide | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 17/66 | 9/66 |
| DiarrhoeaGastrointestinal disorders | 15/66 | 11/66 |
| VomitingGastrointestinal disorders | 13/66 | 8/66 |
| HeadacheNervous system disorders | 10/66 | 12/66 |
| CoughRespiratory, thoracic and mediastinal disorders | 9/66 | 1/66 |
| NasopharyngitisInfections and infestations | 8/66 | 7/66 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 8/66 | 3/66 |
| Upper respiratory tract infectionInfections and infestations | 8/66 | 6/66 |
| PyrexiaGeneral disorders | 7/66 | 5/66 |
| Abdominal painGastrointestinal disorders | 6/66 | 6/66 |
Baseline analysis was performed on FAS that included all randomized participants.
| Age, Continuous(Years) | Oral Semaglutide | Placebo | Total |
|---|---|---|---|
| Mean | 14.4 ± 2.0 | 14.5 ± 2.0 | 14.4 ± 2.0 |
| Sex: Female, Male(Participants) | Oral Semaglutide | Placebo | Total |
|---|---|---|---|
| Female | 41 | 41 | 82 |
| Male | 25 | 25 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Oral Semaglutide | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 20 | 12 | 32 |
| Not Hispanic or Latino | 46 | 54 | 100 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Oral Semaglutide | Placebo | Total |
|---|---|---|---|
| RACE — Asian | 23 | 18 | 41 |
| RACE — Black or African American | 7 | 11 | 18 |
| RACE — Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| RACE — White | 22 | 28 | 50 |
| RACE — Other- Unspecified | 13 | 9 | 22 |
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 Nov 2020 to primary completion in Apr 2025, 53 months.
Results were first posted in Aug 2026, 1 year 3 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 53 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 Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide