Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
NCT03320694 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278
Last updated 2017-10-27
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
Interventions
- DRUG
-
metformin 500mg twice daily \& increased until 2500mg till normoglycemia was achieved and was continued till delivery
- 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
Sponsors & Collaborators
-
Services Institute of Medical Sciences, Pakistan
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-02-01
- Primary Completion
- 2017-06-30
- Completion
- 2017-06-30
Countries
- Pakistan
Study Locations
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