Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Drug: Insulin Mixtard; Drug: Metformin

• Registration Number: NCT03106870
• Lead Sponsor: Ain Shams University

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:

1. History taking:

2. General and Abdominal Examination:

With particular emphasis on :

* Body mass index

* Blood pressure.

* Fundal height .

* Estimated fetal weight .

3. 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.

4. Investigations:

Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:

1. Group I: pregnant women who received oral metformin in addition to insulin therapy.

2. Group II: pregnant women who received insulin therapy only.

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-11
• Results First Submitted: 2017-04-14
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

1. Age 20 - 35 years.
2. Gestational age: 20- 36 weeks gestation.
3. Singleton pregnancy.
4. Women with pregestational or gestational diabetes mellitus

Exclusion Criteria

1. Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
2. Hypertensive patients.
3. Women with impaired liver or renal function
4. Non-compliant patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral metformin and insulin	Insulin Mixtard	Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
insulin therapy only	Insulin Mixtard	Intervention 'Insulin Mixtard' had included
oral metformin and insulin	Metformin	Intervention 'Insulin Mixtard' and Intervention 'metformin' had included

Primary Outcome Measures

Name	Time	Method
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation	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

Name	Time	Method
Number of Participants With a Macrosomic Baby	24 hours after delivery	Fetal macrosomia has been defined birth weight greater than 4500 gm
Number of Participants With Neonates Who Were Hypoglycemic	24 hours after delivery	Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery