Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Metformin
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring Gestational Diabetes Mellitus, Metformin, Insulin
Eligibility 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
Sites / Locations
- Services Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
metformin
Insulin
Arm Description
Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery
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
Outcomes
Primary Outcome Measures
maternal glycemic control
Maternal glycemic control was measured by blood sugar levels
Secondary Outcome Measures
Fetal macrosomia
Birth weight more than 4kg
Apgar score
<7 at 5min
Neonatal intensive care unit (NICU) stay
Admitted to NICU
Perinatal death
Fetal or neonatal death within 7 days
mode of delivery
Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery
Neonatal hypoglycemia
Neonatal blood sugar was checked at birth and if <2.2mmol/l, was labelled
Full Information
NCT ID
NCT03320694
First Posted
September 30, 2017
Last Updated
October 25, 2017
Sponsor
Services Institute of Medical Sciences, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT03320694
Brief Title
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
Official Title
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Institute of Medical Sciences, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
Keywords
Gestational Diabetes Mellitus, Metformin, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Experimental
Arm Description
Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery
Arm Title
Insulin
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
metformin 500mg twice daily & increased until 2500mg till normoglycemia was achieved and was continued till delivery
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Humulin R U 100 and Humulin N
Intervention Description
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
Primary Outcome Measure Information:
Title
maternal glycemic control
Description
Maternal glycemic control was measured by blood sugar levels
Time Frame
From time of randomisation till 40 weeks
Secondary Outcome Measure Information:
Title
Fetal macrosomia
Description
Birth weight more than 4kg
Time Frame
at birth
Title
Apgar score
Description
<7 at 5min
Time Frame
at birth
Title
Neonatal intensive care unit (NICU) stay
Description
Admitted to NICU
Time Frame
>24 hours after birth
Title
Perinatal death
Description
Fetal or neonatal death within 7 days
Time Frame
7 days of delivery
Title
mode of delivery
Description
Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery
Time Frame
at delivery
Title
Neonatal hypoglycemia
Description
Neonatal blood sugar was checked at birth and if <2.2mmol/l, was labelled
Time Frame
at birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Services Institute of Medical Sciences
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
We'll reach out to this number within 24 hrs