Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-03 @ 7:22 AM
Study NCT ID:
NCT03320694
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2017-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
Sponsor:
Services Institute of Medical Sciences, Pakistan
Organization:
Study Overview
Official Title:
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: