A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT04596631
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral semaglutide — DRUG
    Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
  • Placebo (semaglutide) — DRUG
    Placebo treatment for 52 weeks.

Study Details

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.

Key Dates

Start date
Nov 2, 2020
Status verified
Mar 2026
Primary completion
Apr 29, 2025
Completion
Feb 3, 2026

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from baseline in glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, week 26 ]

Locations (23)

FacilityCityStateZIPSite coordinators
UAB Ped Endo Children's HospBirminghamAlabama35233-
Children's Hospital Los Angeles - EndocrinologyLos AngelesCalifornia90027-
Yale School Of MedicineNew HavenConnecticut06520-
Nemours Chld Clnc JacksonvilleJacksonvilleFlorida32207-
Nemours Children's HealthPensacolaFlorida32514-
University of South Florida Diabetes CenterTampaFlorida33612-
Children's Healthcare AtlantaAtlantaGeorgia30329-
Columbus Research FoundationColumbusGeorgia31904-
Indiana Uni School of Med-PedIndianapolisIndiana46202-
University Of Louisville Research FoundationLouisvilleKentucky40202-
Pennington Biomed Res CtrBaton RougeLouisiana70808-4124-
Barry J. Reiner, MD LLCBaltimoreMaryland21229-
University of Mississippi Medical CenterJacksonMississippi39216-
UBMD Peds-Div of Endo/DiabetesBuffaloNew York14203-
UPMC Child Hosp-PittsburghPittsburghPennsylvania15224-
Monument Health Clinical RsrchRapid CitySouth Dakota57701-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Texas Tech University HSCAmarilloTexas79106-
NE Clin Res of San AntonioSan AntonioTexas78233-
Univ Of Texas Hlth Science CntrSan AntonioTexas78207-
Pediatric Endo UVHSCharlottesvilleVirginia22908-
Virginia Commonwealth UnivRichmondVirginia23298-
Virginia Commonwealth University_RichmondRichmondVirginia23298-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
UAB Ped Endo Children's Hosp· Birmingham, ALChildren's Hospital Los Angeles - Endocrinology· Los Angeles, CAYale School Of Medicine· New Haven, CTNemours Chld Clnc Jacksonville· Jacksonville, FLNemours Children's Health· Pensacola, FLUniversity of South Florida Diabetes Center· Tampa, FL

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