Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Drug: Metformin; Drug: Insulin

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

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Services Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: metformin; Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery	Drug: Metformin; metformin 500mg twice daily & increased until 2500mg till normoglycemia was achieved and was continued till delivery; Other Names: Glucophage
ACTIVE_COMPARATOR: 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	Drug: Insulin; 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; Other Names: Humulin R U 100 and Humulin N

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal glycemic control	Maternal glycemic control was measured by blood sugar levels	From time of randomisation till 40 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Services Institute of Medical Sciences, Pakistan

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: September 30, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Gestational Diabetes Mellitus, Metformin, Insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Metformin; Isophane Insulin, Human
• Other Study ID Numbers: IRB/2015/211/SIMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No