Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

NCT03320694 | Completed Phase 3 DMC

• 1 other identifier: IRB/2015/211/SIMS
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Gestational Diabetes Mellitus, Metformin, Insulin

Outcome Measures

Primary Outcomes (1)

• maternal glycemic control

  Maternal glycemic control was measured by blood sugar levels

  From time of randomisation till 40 weeks

Secondary Outcomes (6)

• Fetal macrosomia

  at birth

• Apgar score

  at birth

• Neonatal intensive care unit (NICU) stay

  >24 hours after birth

• Perinatal death

  7 days of delivery

• mode of delivery

  at delivery

Study Arms (2)

metformin

EXPERIMENTAL

Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery

Drug: Metformin

Insulin

ACTIVE COMPARATOR

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

Interventions

Metformin DRUG

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

Also known as: Glucophage

metformin

Insulin DRUG

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

Also known as: Humulin R U 100 and Humulin N

Insulin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Metformin; Insulin; Isophane Insulin, Human

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Isophane; Insulin, Long-Acting; Insulin, Regular, Human

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Obs Gynae

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 25, 2017
• Study Start: February 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

PA (1)