Managing DIabetes Remission After Combined Therapy in EarLy Stage of DiabetEs
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Epidemiologic, social and economic burdens of type 2 diabetes mellitus (T2DM) keep rising
worldwide. Implementation of T2DM preventive trategies is lagging behind. Metabolic surgery,
very low calorie diet can induce T2DM remission, but so far for few patients. The
investigators will assess the efficacy to cause T2DM remission (primary end point) and direct
costs to the National Health System of a 4-month polychemotherapy
(metformin+pioglitazone+sitagliptin+empagliflozin) regimen vs standard care in patients with
newly diagnosed T2DM by an open label, pragmatic RCT. Mechanisms of action will be
investigated in a sub-cohort by a prolonged OGTT plus dual tracer technique and modeling of
beta cell function.
If proved efficacious in this proof-of-concept study and inducer of durable remission in the
future, T2DM polychemotherapy will turn out to be a convenient, relatively unexpensive
strategy to restrain prevalence of T2DM and its complications and to alleviate its personal,
social and economic burden.