Comparison of efficacy and safety of different doses of metformin in women with gestational diabetes mellitus

To evaluate the efficacy for glycaemic control and safety profile of different metformin doses in women with Gestational Diabetes mellitus: a pilot two-arm parallel randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059803

Enrollment

Registered

2023-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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: Metformin: 500 mg once daily for 4 weeks Intervention2: Metformin: 850 mg once daily for 4 weeks Control Intervention1: No drug: Details of glycaemia and symptoms present for 2 weeks be

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women with gestational diabetes mellitus (period of gestation 16-28wks) 2. Live singleton fetus (US done to confirm gestational age, viability and rule out multiple pregnancies) 3. Age = 18 years 4. Enrolled either in the Department of Endocrinology and Metabolism or Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi. 5. Willing to comply with study protocol

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus, secondary diabetes, overt and pre-existing diabetes. 2. Known congenital anomalies in fetus 3. Pre- eclampsia 4. Fetal growth retardation (Abdominal circumference 5. Ruptured membranes 6. Intolerance to metformin (severe vomiting requiring intravenous fluids or hospitalization, active Crohn’s or colitis, presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis, a history of diabetic ketoacidosis or history of lactic acidosis) 7. Women with alcohol intake during pregnancy 8. Congestive heart failure or a history of congestive heart failure and 9. Those with contraindications to metformin (serum creatinine of greater than 130 umol/L or creatinine clearance 3 times upper limit), shock or sepsis, and previous hypersensitivity to metformin)

Design outcomes

Primary

Measure	Time frame
difference of change in mean glucose SMBG log pre intervention values vs values post interventionTimepoint: from randomisation (16-28wks) till delivery	—

Secondary

Measure	Time frame
CGMS Parameters like TIR, TBR, TAR, MG, Day MG, Night MGTimepoint: from randomisation (16-28wks) till 4 weeks post randomisation;composite pregnancy outcomesTimepoint: at delivery;Gestational weight gain per weekTimepoint: from 20wks till delivery;glucose values in target (target pre meals 99 mg/dl & target post meals 126 mg/dl)Timepoint: from randomisation (16-28wks) till delivery;HbA1C levelsTimepoint: at randomisation (16-28wks) & 4 weeks later;in- utero fatal growth restriction (Change in centile of AC 4 weeks apart from baseline)Timepoint: at randomisation (16-28wks), 4 weeks later & at 32-36wks;Maternal & neonatal hypoglycemia incidenceTimepoint: from randomisation(16-28wks) till delivery;maternal GI related adversityTimepoint: from randomisation (16-28wks) till delivery;Need for insulin or metformin beyond 1000 & 1700 mg therapy in the two arms (Defined as after reaching metformin 1000 and 1700 mg dose per day and yet 80% values in target) Timepoint: from randomisation (16-28wks) till delivery;Postpartum OGTT valuesTimepoint: at 6-12 wks postpartum;small for gestational ageTimepoint: at delivery	—

Measure

Time frame

CGMS Parameters like TIR, TBR, TAR, MG, Day MG, Night MGTimepoint: from randomisation (16-28wks) till 4 weeks post randomisation;composite pregnancy outcomesTimepoint: at delivery;Gestational weight gain per weekTimepoint: from 20wks till delivery;glucose values in target (target pre meals 99 mg/dl & target post meals 126 mg/dl)Timepoint: from randomisation (16-28wks) till delivery;HbA1C levelsTimepoint: at randomisation (16-28wks) & 4 weeks later;in- utero fatal growth restriction (Change in centile of AC 4 weeks apart from baseline)Timepoint: at randomisation (16-28wks), 4 weeks later & at 32-36wks;Maternal & neonatal hypoglycemia incidenceTimepoint: from randomisation(16-28wks) till delivery;maternal GI related adversityTimepoint: from randomisation (16-28wks) till delivery;Need for insulin or metformin beyond 1000 & 1700 mg therapy in the two arms (Defined as after reaching metformin 1000 and 1700 mg dose per day and yet 80% values in target) Timepoint: from randomisation (16-28wks) till delivery;Postpartum OGTT valuesTimepoint: at 6-12 wks postpartum;small for gestational ageTimepoint: at delivery

—

Countries

India

Contacts

Public ContactSankeerth Sadananda

All India Institute of Medical Sciences,New Delhi

yashdeep@aiims.edu01126593645

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026