Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insulin Mixtard
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Age 20 - 35 years.
- Gestational age: 20- 36 weeks gestation.
- Singleton pregnancy.
- Women with pregestational or gestational diabetes mellitus
Exclusion Criteria:
- Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
- Hypertensive patients.
- Women with impaired liver or renal function
- Non-compliant patients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
oral metformin and insulin
insulin therapy only
Arm Description
Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Intervention 'Insulin Mixtard' had included
Outcomes
Primary Outcome Measures
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:
60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus
Secondary Outcome Measures
Number of Participants With a Macrosomic Baby
Fetal macrosomia has been defined birth weight greater than 4500 gm
Number of Participants With Neonates Who Were Hypoglycemic
Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03106870
Brief Title
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
Official Title
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
Detailed Description
The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.
All patients were subjected to:
History taking:
General and Abdominal Examination:
With particular emphasis on :
Body mass index
Blood pressure.
Fundal height .
Estimated fetal weight .
Insulin and metformin doses :
Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin dose :
Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
Investigations:
Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:
Group I: pregnant women who received oral metformin in addition to insulin therapy.
Group II: pregnant women who received insulin therapy only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group I: pregnant women who received oral metformin in addition to insulin therapy.
Group II: pregnant women who received insulin therapy only.
Masking
Participant
Masking Description
Sixty-two opaque envelopes were numbered serially and in each envelope the corresponding letter which detect allocated group were put according to randomization then all envelops were closed and put in one box .When the first patient arrives , the first envelope were opened and the patient were allocated according to the letter inside .
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral metformin and insulin
Arm Type
Active Comparator
Arm Description
Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Arm Title
insulin therapy only
Arm Type
Active Comparator
Arm Description
Intervention 'Insulin Mixtard' had included
Intervention Type
Drug
Intervention Name(s)
Insulin Mixtard
Other Intervention Name(s)
insulin mixtures
Intervention Description
Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Metformin Hydrocloride
Intervention Description
Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
Primary Outcome Measure Information:
Title
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
Description
Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:
60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus
Time Frame
from 20 weeks to 36 weeks gestation
Secondary Outcome Measure Information:
Title
Number of Participants With a Macrosomic Baby
Description
Fetal macrosomia has been defined birth weight greater than 4500 gm
Time Frame
24 hours after delivery
Title
Number of Participants With Neonates Who Were Hypoglycemic
Description
Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery
Time Frame
24 hours after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 20 - 35 years.
Gestational age: 20- 36 weeks gestation.
Singleton pregnancy.
Women with pregestational or gestational diabetes mellitus
Exclusion Criteria:
Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
Hypertensive patients.
Women with impaired liver or renal function
Non-compliant patients.
12. IPD Sharing Statement
Plan to Share IPD
No
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Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
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