A clinical trial to compare the effects of metformin versus insulin in patients with diabetes in pregnancy.

Study of the efficacy and safety of metformin versus insulin in gestational diabetes mellitus in a tertiary care center in eastern india - MvIG

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/08/004835

Enrollment

100

Registered

2014-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Gestational Diabetes Mellitus

Interventions

Intervention1: Drug: metformin: oral, 500 mg to 2500 mg,once or twice daily in divided dosages, for 8 to 20 weeks (until delivery) Control Intervention1: Drug: insulin: subcutaneous (s.c), Neutral Pro

Eligibility

Inclusion criteria

Inclusion criteria: Mothers with gestational diabetes who has at least one plasma glucose at 24 to 33 gestational weeks Fasting > 92 mg/dl (5.1 mmol/L) and/or 1 hour post 75 gm glucose value > 180 mg/dl (10 mmol/L) and/or 2 hour post 75 gm glucose value > 153 mg/dl (8.5 mmol/L)

Exclusion criteria

Exclusion criteria: 1. Diagnosis of diabetes before 24 weeks of pregnancy 2. Prepregnancy diagnosis of diabetes 3. HbA1c > 7.5 % 4. Renal, hepatic or cardiac failure 5. Diabetic ketoacidosis 6. Pregnancy with multiple fetuses 7. Fetal growth restriction 8. Ruptured membranes 9. A fetal anomaly 10. Bad obstetric history 11. Preeclampsia & eclampsia 12. Chronic hypertension 13. Other major comorbid illness 14. Placental abnormalities or low lying placenta 15. Oligohydroamnios or polyhydroamnios 16. Gestational Hypertention 17. Unwilling to participate in the study

Design outcomes

Primary

Measure	Time frame
1. Birth weight 2. Birth weight adjusted for gestational weeks Timepoint: 1. 0-24 h after delivery 2. 0-24 h after delivery	—

Secondary

Measure	Time frame
1. Gestational hypertension 2. Maternal weight gain 3. Pre-eclampsia 4. Mode of delivery 5. Gestational weeks at delivery 6. Induction of delivery 7. Shoulder dystocia 8. Neonatal hyperbilirubinemia 9. Neonatal hypoglycemia 10. Apgar score at 5 min after delivery 11. Neonate transfer to intensive care unit 12. Respiratory distress 13. Preterm birth (37 wk of gestation) 14. Acceptability of treatmentTimepoint: 1. up to on the average 40 weeks of gestation 2. up to on the average 40 weeks of gestation 3. up to on the average 40 weeks of gestation 4. delivery 5. delivery 6. delivery 7. delivery 8. 0-3 days after delivery 9. 0-24 h after delivery 10. 5 minutes after delivery 11. 0-5 days after delivery 12. 0-24 h after delivery 13. delivery 14. 0-7 days after delivery	—

Measure

Time frame

1. Gestational hypertension 2. Maternal weight gain 3. Pre-eclampsia 4. Mode of delivery 5. Gestational weeks at delivery 6. Induction of delivery 7. Shoulder dystocia 8. Neonatal hyperbilirubinemia 9. Neonatal hypoglycemia 10. Apgar score at 5 min after delivery 11. Neonate transfer to intensive care unit 12. Respiratory distress 13. Preterm birth (37 wk of gestation) 14. Acceptability of treatmentTimepoint: 1. up to on the average 40 weeks of gestation 2. up to on the average 40 weeks of gestation 3. up to on the average 40 weeks of gestation 4. delivery 5. delivery 6. delivery 7. delivery 8. 0-3 days after delivery 9. 0-24 h after delivery 10. 5 minutes after delivery 11. 0-5 days after delivery 12. 0-24 h after delivery 13. delivery 14. 0-7 days after delivery

—

Countries

India

Contacts

Public ContactDr Prashant Somani

N R S Medical College and Hospital 138 A J C Bose Road Kolkata

pranabsahana@gmail.com9231523624

Outcome results

None listed

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