NCT03320694

Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Services Institute of Medical Sciences, Pakistan · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DRUG	Metformin	metformin 500mg twice daily \& increased until 2500mg till normoglycemia was achieved and was 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

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2017-10-25
• Last updated: 2017-10-27

Locations

1 site across 1 country: Pakistan