Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point
| Group | Value (Percentage point) | Spread |
|---|---|---|
| Oral Semaglutide | -1.0 | 1.5 |
| Placebo | -0.3 | 1.3 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name PIONEER TEENS
United States, Australia, Austria, Belgium, Czechia, Greece, India, Israel, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Portugal, Puerto Rico, Romania, Russia, Taiwan, Ukraine, United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Semaglutide - max. tolerated dose
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.
Placebo comparator
Placebo (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.
Outcomes the sponsor listed as primary.
Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point
Time frame · Baseline (Week 0), Week 26
This outcome measure reports change from baseline to week 26 in HbA1c measured in terms of percentage point.
Change From Baseline (Week 0) in HbA1c to Week 26- Millimoles Per Mole (mmol/Mol)
Time frame · Baseline (Week 0), Week 26
This outcome measure reports change from baseline to week 26 in HbA1c in terms of mmol/mol.
Change From Baseline (Week 0) in Fasting Plasma Glucose (FPG) to Week 26
Time frame · Baseline (Week 0), Week 26
This outcome measure reports change from baseline in FPG to week 26 measured in terms of milligrams per deciliter (mg/dL).
Change From Baseline (Week 0) in Body Mass Index (BMI) Standard Deviation Score (SDS) to Week 26
Time frame · Baseline (Week 0), 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).
Change From Baseline in HbA1c at Week 52 (Percentage Point)
Time frame · Baseline (Week 0), Week 52
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of percentage point.
Change From Baseline in HbA1c at Week 52 (mmol/Mol)
Time frame · Baseline (Week 0), Week 52
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of mmol/mol.
Change From Baseline in Fasting Plasma Glucose at Week 52 (mg/dL)
Time frame · Baseline (Week 0), Week 52
This outcome measure reports change from baseline to week 52 in FPG measured in terms of mg/dL.
Change From Baseline in Body Weight to Week 26 and Week 52 (Kilograms [kg])
Time frame · Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline to week 26 and week 52 in body weight measured in terms of kg.
Relative Change From Baseline in Body Weight to Week 26 and Week 52
Time frame · Baseline (Week 0), Week 26, 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.
Change From Baseline in Waist Circumference to Week 26 and Week 52
Time frame · Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline to week 26 and week 52 in Waist circumference measured in terms of centimeters (cm).
Change From Baseline in Body Mass Index Standard Deviation Score at Week 52
Time frame · Baseline (Week 0), 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)
Change From Baseline (Week 0) in BMI Percentile (Age and Gender Adjusted) to Week 26 and Week 52
Time frame · Baseline (Week 0), Week 26, 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.
Change From Baseline in Body Mass Index at Week 26 and Week 52
Time frame · Baseline (Week 0), Week 26, 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).
Percent Change From Baseline in Body Mass Index at Week 26 and Week 52
Time frame · Baseline (Week 0), Week 26, Week 52
This outcome measure reports percent change from baseline to week 26 and week 52 in BMI measured in terms of percent change.
Change From Baseline (Week 0) in Body Mass Index Percentage of the 95th Percentile to Week 26 and to Week 52
Time frame · Baseline (Week 0), Week 26, 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.
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 26 and Week 52
Time frame · Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline in systolic and diastolic blood pressure at week 26 and week 52.
Percentage of Participants With HbA1c Less Than (<) 7.0% (53 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)
Time frame · At Week 26 and Week 52
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 With HbA1c Less Than or Equals (≤) 6.5% (48 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)
Time frame · At Week 26 and Week 52
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.
Number of Events With Initiation of Additional Anti-diabetic Medication
Time frame · At Week 52
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.
Number of Events With Initiation of Rescue Medication
Time frame · At Week 52
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.
Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product for All Participants
Time frame · From Baseline (Week 0) to Week 57
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.
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes From Randomization to Week 26 for All Participants
Time frame · From Baseline (Week 0) to Week 26
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)?
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage point) | Spread |
|---|---|---|
| Oral Semaglutide | -1.0 | 1.5 |
| Placebo | -0.3 | 1.3 |
| Group | Value (mmol/mol) | Spread |
|---|---|---|
| Oral Semaglutide | -11.2 | 16.5 |
| Placebo | -2.8 | 14.3 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Oral Semaglutide | -28.2 | 49.1 |
| Placebo | -8.1 | 65.1 |
| Group | Value (standard deviation score) | Spread |
|---|---|---|
| Oral Semaglutide | -0.1 | 0.3 |
| Placebo | -0.1 | 0.3 |
| Group | Value (Percentage point) | Spread |
|---|---|---|
| Oral Semaglutide | -0.8 | 1.4 |
| Placebo | 0.2 | 1.4 |
| Group | Value (mmol/mol) | Spread |
|---|---|---|
| Oral Semaglutide | -9.0 | 15.8 |
| Placebo | 2.5 | 14.8 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Oral Semaglutide | -21.2 | 54.8 |
| Placebo | 2.2 | 53.8 |
| Group | Value (kg) | Spread |
|---|---|---|
| Oral Semaglutide | -1.3 | 4.1 |
| Placebo | -0.4 | 5.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oral SemaglutideParticipants with T2D received oral semaglutide tablets once daily in a dose escalation manner (a starting dose of 3 mg for 4 weeks followed by dose escalations to 7 mg and 14 mg with minimum 4-week intervals depending on the maximum tolerated dose) for 52 weeks treatment period followed by a 12-week off-trial product follow-up period. | 0 / 66 | 5 / 66 | 45 / 66 |
| PlaceboParticipants with T2D received placebo matching semaglutide oral tablets once daily for 52 weeks during the treatment period followed by a 12-week off-trial product follow-up period. | 0 / 66 | 2 / 66 | 40 / 66 |
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