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To compare effectiveness and safety of 2 drugs used to treat gestational diabetes mellitus, one of which is oral drug, another is injectable medication.

Insulin versus metformin for the treatment of gestational diabetes mellitus A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037386
Enrollment
90
Registered
2021-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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: to study the extent of glycemic control with the use of metformin in women with GDM Route Oral Dose According to Blood Sugar Dose 500 mg to 2 gm Control Intervention1: insu

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pregnant women between 18-45 years of age. 2.Singleton pregnancies at 26-30 weeks of Period of gestation. 3.Pregnant women Diagnosed with GDM according to IADPSG criteria (International association of diabetes and pregnancy study group) who failed to control on MNT only.

Exclusion criteria

Exclusion criteria: 1.Contraindication to Metformin (Chronic Heart failure, Metabolic acidosis, Diabetic ketoacidosis, Severe Renal disease and pulmonary disease). 2.Medical Disorder (Chronic Hypertension, Type 1 and 2 Diabetes mellitus, Liver disease). 3.Fetal anomaly 4. Intra uterine fetal growth restriction. 5. With macrosomia and polyhydramnios 6. Fasting blood sugar =126 mg/dl and Post Prandial blood sugar = 200 mg/dl 7 . Preterm ruptured membrane. 8. Patient not giving consent

Design outcomes

Primary

MeasureTime frame
To assess successful maternal glycemic control in Gestational Diabetes Mellitus after 2 weeks of starting the pharmacological treatment. Timepoint: from 24 weeks POG till 6 weeks postpartum

Secondary

MeasureTime frame
1.To compare HBA1c in both the groups at 36-38 week of period of gestation. 2 .To compare the clinical evidence of macrosomia and polyhydramnios in pregnancies complicated by GDM on insulin or metformin. Timepoint: from 24 weeks POG till 6 weeks postpartum

Countries

India

Contacts

Public ContactManisha Jhirwal

AIIMS, Jodhpur

escatic.manisha@gmail.com7042657811

Outcome results

None listed

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