Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Phase 3

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Drug: Insulin; Drug: Metformin

• Registration Number: NCT03320694
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Brief Summary

Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) \<5.3 mmol/l and 1 hour post meal\<7.8mmol/l. Both groups were followed till delivery and outcome studied.

Detailed Description

75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) \> 5.5 mmol/l \& 2 hours postprandial \>7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily \& increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF \<5.3 mmol/l and 1 hour post meal\<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin \& one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Study First Submitted: 2017-09-30
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-25
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 278

Inclusion Criteria

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• All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy

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Exclusion Criteria

• Patients with Known diabetes mellitus
• Patients with multiple pregnancy
• With essential hypertension or pre eclampsia
• Patients having fetal malformation incompatible with life
• Patients with intrauterine death of fetus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin	Insulin	Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery
metformin	Metformin	Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery

Primary Outcome Measures

Name	Time	Method
maternal glycemic control	From time of randomisation till 40 weeks	Maternal glycemic control was measured by blood sugar levels

Secondary Outcome Measures

Name	Time	Method
Neonatal hypoglycemia	at birth	Neonatal blood sugar was checked at birth and if \<2.2mmol/l, was labelled
Perinatal death	7 days of delivery	Fetal or neonatal death within 7 days
mode of delivery	at delivery	Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery
Fetal macrosomia	at birth	Birth weight more than 4kg
Apgar score	at birth	\<7 at 5min
Neonatal intensive care unit (NICU) stay	>24 hours after birth	Admitted to NICU

Trial Locations

Locations (1)

Services Institute of Medical Sciences; 🇵🇰 Lahore, Punjab, Pakistan