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Comparison of Metformin with Glyburide in gestational diabetes

Metformin vs Glyburide in gestational diabetes- A randomised controlled trial - None

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/02/004418
Enrollment
160
Registered
2014-02-18
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- Pregnant women with gestational diabetes not controlled with medical nutritional therapy (MNT)

Interventions

Intervention1: Metformin: Pregnant women recruited to receive metformin will be started on 500mg, once a day and this will also be increased in a weekly stepwise manner to a maximum of 2500 mg a day

Sponsors

Christian Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women from 20-33 weeks Fasting glucose >=99mg% and = 120mg% and

Exclusion criteria

Exclusion criteria: Pre-existing type 1 or 2 diabetes Currently taking metformin for some other indication. Multiple pregnancy. Recognised foetal congenital anomaly. Known abnormal renal or liver function. Hypoxic cardio-respiratory disease. Mal-absorption or some other significant GI disease. Sepsis. Ruptured membranes. Gestational hypertension or pre-eclampsia.

Design outcomes

Primary

MeasureTime frame
The Primary outcome of the study were a composite of salient neonatal outcomes that include: â?¢Macrosomia â?¢Birth weight more than 3700gms â?¢Hypoglycaemia less than 40mg percent â?¢Need for phototherapy â?¢Respiratory distress â?¢Stillbirth or neonatal deaths â?¢Birth trauma Timepoint: 20 percent

Secondary

MeasureTime frame
Secondary outcomes include: â?¢Birth weight â?¢Maternal glycaemic control â?¢Pregnancy induced hypertension â?¢Need for induction of labour â?¢mode of delivery â?¢complications of delivery such as third and fourth degree perineal tears. Timepoint: 30 percent

Countries

India

Contacts

Public ContactJiji Elizabeth Mathews

Christian Medical College and Hospital

annegc97@yahoo.co.in914162286172

Outcome results

None listed

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