Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Drug: Insulin Mixtard
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral metformin and insulin<br>Intervention 'Insulin Mixtard' and Intervention 'metformin' had included | Drug: Insulin Mixtard<br>* 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.<br>* Other names: insulin mixtures;Drug: Metformin<br>* 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.<br>* Other names: Metformin Hydrocloride;|
| Active Comparator: insulin therapy only<br>Intervention 'Insulin Mixtard' had included | Drug: Insulin Mixtard<br>* 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.<br>* Other names: insulin mixtures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from 20 weeks to 36 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Macrosomic Baby | Fetal macrosomia has been defined birth weight greater than 4500 gm | 24 hours after delivery | 
| 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 | 24 hours after delivery |