A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo (semaglutide)
- Registration Number
- NCT04596631
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 132
- Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Male or female, aged 10 to below 18 years at the day of randomisation
- HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive)
- Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with:
- stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or
- stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or
- stable dose of basal insulin
- Diagnosis of type 1 diabetes
- Maturity onset diabetes of the young (MODY)
- Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (semaglutide) 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. Semaglutide - max. tolerated dose Oral semaglutide 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.
- Primary Outcome Measures
Name Time Method Change from baseline in glycosylated haemoglobin (HbA1c) Week 0, week 26 Percentage point
- Secondary Outcome Measures
Name Time Method Anti-semaglutide antibody titer Up to 57 weeks Count of participants
Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide Week 0 to week 57 Count of participants
Height velocity At week 52 cm/year
Change from baseline in pubertal assessment (Tanner staging) Week 0, week 52 Stage 1-5 where 5 is full sexual maturity
Change from baseline in pulse rate Week 0, week 52 Beats/minute
Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product Week 0 - week 57 Count of episodes
Change from baseline in prolactin Week 0, week 52 mIU/L
Time to rescue medication (to support the hypothetical estimand) Week 0 - week 52 Days
Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode From randomisation (week 0) to week 26 Count of participants
Treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product Week 0 - week 57 Count of participants
Change from baseline in amylase Week 0, week 52 U/L
Change from baseline in lipase Week 0, week 52 U/L
Change from baseline in insulin-like growth factor 1 (IGF-1) Week 0, week 52 ng/mL
Change from baseline in dehydroepiandrosterone sulfate (DHEAS) Week 0, week 52 μmol/L
Change from baseline in bone age assessment, X-ray Week 0, week 52 Years
Change from baseline in luteinizing hormone (LH) Week 0, week 52 mIU/mL
HbA1c below 7.0% (53 mmol/mol) (yes/no), ADA target and ISPAD guidelines from 2018 At week 52 Count of participants
Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3) Week 0, week 52 ng/mL
Change from baseline in calcitonin Week 0, week 52 pmol/L
Change from baseline in FPG Week 0, week 52 mmol/L
Relative change from baseline in body weight Week 0, week 52 Percentage
HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), American Association of Clinical Endocrinologists (AACE) target At week 26 Count of participants
Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes From randomisation (week 0) to week 26 Count of episodes
Change from baseline in fasting plasma glucose (FPG) Week 0, week 26 mmol/L
Change from baseline in body mass index (BMI) standard deviation score (SDS) Week 0, week 26 SDS
Change from baseline in body weight Week 0, week 52 kg
Change from baseline in systolic blood pressure Week 0, week 52 mmHg
Change from baseline in estradiol (for girls) Week 0, week 52 pmol/L
Change from baseline in testosterone (for boys) Week 0, week 52 nmol/L
Change from baseline in glycosylated haemoglobin (HbA1c) Week 0, week 52 Percentage point
Change from baseline in waist circumference Week 0, week 52 cm
Change from baseline in BMI SDS Week 0, week 52 SDS
BMI percentile (age and gender adjusted) Week 0, week 52 Percent
Change from baseline in diastolic blood pressure Week 0, week 52 mmHg
HbA1c below 7.0% (53 mmol/mol) (yes/no), American Diabetes Association (ADA) target and International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines from 2018 At week 26 Count of participants
HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), AACE targetat week 26 At week 52 Count of participants
Number of treatment-emergent adverse events (TEAEs) during exposure to trial product Week 0 - week 57 Count of events
Change from baseline in thyroid stimulating hormone (TSH/thyrotropin) Week 0, week 52 mIU/L
Time to additional anti-diabetic medication (to support the treatment policy estimand) Week 0 - week 52 Days
Change from baseline in follicle stimulating hormone (FSH) Week 0, week 52 mIU/mL
Apparent clearance (CL/F) Week 0 - week 52 L/h
SNAC plasma concentrations Week 0 - week 52 ng/mL
Anti-semaglutide antibodies cross reacting with endogenous GLP-1 Week 0 to week 57 Count of participants
Change from pre-dose to post-dose (25 and 40 min) in lactate At week 26 mmol/L
Average concentration (Cavg) Week 0 - week 52 nmol/L
Anti-semaglutide antibody status Week 0 - week 57 Count of participants
Cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1 Week 0 to week 57 Count of participants
Change from baseline in height SDS Week 0, week 26 SDS
Trial Locations
- Locations (61)
Soroka MC - Pediatric Endocrinology
🇮🇱Beer Sheva, Israel
Rambam MC - Department of Pediatrics A
🇮🇱Haifa, Israel
Taipei Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Children's Hospital Los Angeles - Endocrinology
🇺🇸Los Angeles, California, United States
Nemours Chld Clnc Jacksonville
🇺🇸Jacksonville, Florida, United States
University of South Florida Diabetes Center
🇺🇸Tampa, Florida, United States
Children's Healthcare Atlanta
🇺🇸Atlanta, Georgia, United States
Indiana Uni School of Med-Ped
🇺🇸Indianapolis, Indiana, United States
University Of Louisville Research Foundation
🇺🇸Louisville, Kentucky, United States
Barry J. Reiner, MD LLC
🇺🇸Baltimore, Maryland, United States
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