Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Services Institute of Medical Sciences, Pakistan

Status and phase: Completed; Phase 3

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Drug: Metformin; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03320694

IRB/2015/211/SIMS

Details and patient eligibility

About

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.

Full 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

Enrollment: 278 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Insulin

Active Comparator group

Description:

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

Treatment:

Drug: Insulin