Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320694
• Other study ID #: IRB/2015/211/SIMS
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2017
• Last updated: October 25, 2017
• Start date: February 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2017
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

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

Locations

Country	Name	City	State
Pakistan	Services Institute of Medical Sciences	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal glycemic control	Maternal glycemic control was measured by blood sugar levels	From time of randomisation till 40 weeks
Secondary	Fetal macrosomia	Birth weight more than 4kg	at birth
Secondary	Apgar score	<7 at 5min	at birth
Secondary	Neonatal intensive care unit (NICU) stay	Admitted to NICU	>24 hours after birth
Secondary	Perinatal death	Fetal or neonatal death within 7 days	7 days of delivery
Secondary	mode of delivery	Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery	at delivery
Secondary	Neonatal hypoglycemia	Neonatal blood sugar was checked at birth and if <2.2mmol/l, was labelled	at birth