Liraglutide Trial Explores Preserving Insulin Secretion, Delaying Type 1 Diabetes Onset in At-Risk Youth

The autoimmune destruction of pancreatic beta cells in Type 1 Diabetes (T1D) leads to absolute insulin deficiency, requiring lifelong exogenous insulin. Current therapies manage symptoms but do not prevent disease onset or halt beta cell loss. Individuals in the late preclinical T1D stage, characterized by multiple islet autoantibodies and dysglycemia, face imminent progression to overt disease. GLP-1 receptor agonists like liraglutide have demonstrated beta-cell protective effects and improved insulin sensitivity in Type 2 Diabetes. This trial investigates whether such an incretin-based therapy can preserve endogenous insulin secretion and delay T1D progression in this high-risk population.

This was a randomized, quadruple-blinded, prevention Phase 2 trial (NCT02898506) involving N=13 subjects aged 10-30 years with at least two islet autoantibodies and dysglycemia. Participants received daily subcutaneous injections of either liraglutide (Victoza®) or placebo, with doses gradually increasing up to 1.8 mg/day over 6 months. This was followed by a 6-month observation period. The primary endpoint was the FPIR (First Phase Insulin Response) during a 10-min IVGTT (intravenous glucose tolerance test) measured at 12 months.

This record describes the design and objectives of a completed Phase 2 clinical trial (NCT02898506) investigating liraglutide in late preclinical Type 1 Diabetes. The primary objective was to determine if daily liraglutide treatment improves endogenous insulin secretion and postpones progression to overt Type 1 Diabetes. Secondary outcomes included safety, tolerability, and serum C-peptide AUC. However, the provided information is a trial registration and does not contain any results, specific numbers, p-values, or statistical findings from the study. Therefore, no findings can be reported at this time.