Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Phase 3CompletedNCT03320694

Services Institute of Medical Sciences, Pakistan278 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

278

Conditions

Gestational Diabetes Mellitus in Pregnancy

Interventions

MetforminDRUG

metformin 500mg twice daily \& increased until 2500mg till normoglycemia was achieved and was continued till delivery

InsulinDRUG

The insulin group was given 3 S/C injections of regular insulin \& one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

maternal glycemic control

Maternal glycemic control was measured by blood sugar levels

Time frame: From time of randomisation till 40 weeks

Secondary Outcomes

Fetal macrosomia

Birth weight more than 4kg

Time frame: at birth

Apgar score

\<7 at 5min

Time frame: at birth

Neonatal intensive care unit (NICU) stay

Admitted to NICU

Time frame: >24 hours after birth

Perinatal death

Fetal or neonatal death within 7 days

Time frame: 7 days of delivery

mode of delivery

Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery

Time frame: at delivery

Neonatal hypoglycemia

Neonatal blood sugar was checked at birth and if \<2.2mmol/l, was labelled

Time frame: at birth

Data from ClinicalTrials.gov

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