NNC0114-0006 and Liraglutide trial investigates beta-cell preservation in newly diagnosed Type 1 Diabetes

For individuals with Type 1 Diabetes Mellitus (T1DM), the autoimmune destruction of pancreatic beta-cells leads to absolute insulin deficiency, necessitating lifelong exogenous insulin therapy. Current treatments manage blood glucose but do not halt beta-cell loss or restore endogenous insulin production. Preserving residual beta-cell function, even partially, could significantly improve glycemic control, reduce hypoglycemic events, and potentially mitigate long-term complications. This trial investigates novel strategies, including a GLP-1 receptor agonist like liraglutide and the investigational compound NNC0114-0006, for their potential to protect these vital insulin-producing cells.

This was a global, Phase 2, randomized, double-blind, double-dummy, placebo-controlled, parallel-group multicenter clinical proof-of-principle trial. A total of 308 adult subjects with newly diagnosed Type 1 Diabetes Mellitus were enrolled. Participants continued their pre-trial insulin treatment while receiving one of four interventions: NNC0114-0006 12 mg/kg intravenously (i.v.) every 6 weeks plus placebo subcutaneously (s.c.) daily; Liraglutide 1.8 mg s.c. daily plus placebo i.v. every 6 weeks; a combination of NNC0114-0006 12 mg/kg i.v. every 6 weeks and Liraglutide 1.8 mg s.c. daily; or dual placebo. The primary aim was to assess the effect on preservation of beta-cell function.