Drug InterVentIon for preveNtion of type 2 diabEtes among women with prior gestational diabetes mellitus and pre-diabetes in South Asia (DIVINE) - A Randomized Control Trial

Given the high prevalence of Gestational Diabetes Mellitus (GDM) with high conversion rates to T2DM after child birth in South Asia, prevention of T2DM is a key policy focus in the region. The focus on preventive strategies in the younger population has been on lifestyle interventions. With limited evidence base on effective and affordable lifestyle approaches in resource-constraint settings, a need was felt to investigate low-cost and scalable preventive drug therapies.

The study planned is a randomized, double-blind placebo controlled trial to evaluate the effectiveness of combination of metformin and vildagliptin in prevention of diabetes in women with prior GDM and having prediabetes in the postpartum period. Women with recent GDM will be approached and screened for pre-diabetes. Pre-diabetic women will be given a 1-month run-in with Metformin SR (500 mg for 2 weeks/1000 mg for 2 weeks) once daily. Patients with more than 80% compliance will be randomized into two groups: Intervention - combination of vildagliptin 100 mg and metformin 1000mg once daily; Control - placebo mimicking drug combination once daily. Planned median treatment and follow-up will continue for 24 months with development of T2DM by OGTT (using ADA) being the primary outcome.

If this drug combination comes out to be efficacious and safe, the results will impact guideline recommendations not just in South Asia and other lower middle income group setting with a similar GDM disease burden but also high-risk population globally.