An open-label, randomized, parallel design trial to compare the efficacy of a sitagliptin-based metabolic intervention versus standard diabetes therapy in inducing remission of type 2 diabetes.
To determine if in patients with recently-diagnosed T2DM, a 12-week course of sitagliptin, metformin, basal insulin glargine and lifestyle approaches will achieve drug-free diabetes remission in a higher proportion of patients than standard diabetes therapy at 24 weeks (3 months after the drugs are stopped). Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with sitagliptin, metformin, insulin glargine and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks.
This is a multicentre, open-label, randomized controlled trial in patients with recently-diagnosed T2DM.
The primary outcome in this trial will be diabetes remission evaluated at 24 weeks.
Natalia McInnes, Hertzel Gerstein