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Metformin versus insulin for blood sugar control and pregnancy outcomes in gestational diabetes

Metformin Versus Insulin Therapy in Early Gestational Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108930
Enrollment
90
Registered
2026-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Intervention1: tab metfromin 500mg: tab metformin 500mg BD and it will be increased as needed up to 2 gm/day at 15 days Intervention2: injection inuslin: subcutaneous insulin will be started including

Sponsors

Adeeba Naseem
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women diagnosed with GDM before 24 weeks of gestation. Pregnant women with a singleton pregnancy

Exclusion criteria

Exclusion criteria: Pregnant women with pre-existing type 1 or type 2 diabetes 2. Pregnant women with multiple gestations (e.g., twins, triplets). 3. Pregnant women with severe medical conditions that may affect glucose metabolism or fetal growth (e.g., chronic kidney disease, liver disease). 4. Pregnant women with PCOS on Metformin. 5. Pregnant women with a known allergy or intolerance to metformin or insulin. 6. Pregnant women currently taking medications that may interact with metformin or insulin (e.g., corticosteroids, beta-blockers). 7. Pregnant women with known fetal anomalies or congenital abnormalities. 8. Pregnant women who do not give informed consent.

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the effectiveness of metformin vs insulin in achieving target blood glucose levels in pregnant women with early GDM.Timepoint: 2 weeks

Secondary

MeasureTime frame
To compare the impact of metformin and insulin on maternal outcomes. To compare the impact of metformin and insulin on fetal outcomes Timepoint: 18 months

Countries

India

Contacts

Public ContactProf Nishat Akhtar

jawaharlal nehru medical college and hospital aligarh muslim university

nishatamu@rediffmail.com817108866

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026