Liraglutide in Adolescents With Type 2 Diabetes and Obesity
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pediatric Obesity
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open label extension investigating the effects of liraglutide 3.0 mg/day on BMI, insulin sensitivity, and glycemic control compared to placebo plus standard treatment (metformin + insulin) in adolescents with T2D.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Participants during the first six months of the study will be randomized to receive either liraglutide or placebo. Neither the participant, care provider, investigator or study team will know whether the participant is receiving liraglutide or placebo.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 20 years
- Gender
- Both males and females
Description
This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open-label extension, investigating the effects of liraglutide 3.0mg/day on BMI, insulin sensitivity, and glycemic control compared to placebo plus standard treatment (metformin+insulin) in ad...
This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open-label extension, investigating the effects of liraglutide 3.0mg/day on BMI, insulin sensitivity, and glycemic control compared to placebo plus standard treatment (metformin+insulin) in adolescents with T2D. The purpose of this study is to 1) evaluate the effects of liraglutide3.0 mg/day vs. placebo+ standard treatment on BMI in adolescents with T2D and obesity and 2) evaluate the effects of liraglutide 3.0 mg/day vs. placebo + standard treatment on insulin sensitivity and B-cell function in adolescents with T2D and obesity.
Tracking Information
- NCT #
- NCT04881799
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Megan Bensignor, MD University of Minnesota
Get Well Soon