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A study to assess the effect of a combination of glucose lowering medicines in prevention of type 2 diabetes among women with previous history of gestational diabetes mellitus and having pre-diabetes

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 - DIVINE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067588
Enrollment
1110
Registered
2024-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Drug InterVentIon for preveNtion of type 2 diabEtes (DIVINE): All participants will undergo 4-weeks active run-in with metformin SR (500mg for 2 weeks / 1000mg daily for 2 weeks) once d
metformin SR 1000mg daily + vildagliptin 100mg once daily and vildagliptin placebo + metformin placebo once daily. All participants will be offered a lifestyle intervention. Control Intervention1: Pla

Sponsors

Indian Council of Medical Research (ICMR)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Most recent pregnancy affected by GDM within past 60 months 2. Currently diagnosed to be pre-diabetic

Exclusion criteria

Exclusion criteria: 1. Pregnancy planned or inadequate contraception 2. Currently pregnant or lactating 3. Established Type 2 Diabetes Mellitus 4. Known renal insufficiency, liver disease and/or anaemia 5. Intolerance to either metformin or vildagliptin 6. Other indication of metformin

Design outcomes

Primary

MeasureTime frame
Proportion of women who develop type 2 diabetes mellitus, at or prior to final visit (based on oral glucose tolerance test)Timepoint: At 6 months, 12 months, 18 months, 24 months—

Secondary

MeasureTime frame
Proportion of women with change in glycaemic category to normal glucose tolerance (based on Oral Glucose Tolerance Test), BMI, Waist circumference, Health-related quality of life, Treatment tolerabilityTimepoint: At 6 months, 12 months, 18 months, 24 months—

Countries

India

Contacts

Public ContactDr Nikhil Tandon

All India Institute of Medical Sciences

nikhil_tandon@hotmail.com01126593433

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026