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OpenTrials
Completed

NCT Number: NCT03320694

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Other names: Glucophage

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

Other names: Humulin R U 100 and Humulin N

Primary outcomes

  1. maternal glycemic control

    Time frame: From time of randomisation till 40 weeks

    Maternal glycemic control was measured by blood sugar levels

Secondary outcomes

  1. Fetal macrosomia

    Time frame: at birth

    Birth weight more than 4kg

  2. Apgar score

    Time frame: at birth

    <7 at 5min

  3. Neonatal intensive care unit (NICU) stay

    Time frame: >24 hours after birth

    Admitted to NICU

  4. Perinatal death

    Time frame: 7 days of delivery

    Fetal or neonatal death within 7 days

  5. mode of delivery

    Time frame: at delivery

    Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery

  6. Neonatal hypoglycemia

    Time frame: at birth

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

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2017
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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