Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106870
• Other study ID #: Metformin
• Status: Completed
• Phase: N/A
• First received: March 28, 2017
• Last updated: April 4, 2017
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Drug:
• Insulin Mixtard
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 didnot reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus	from 20 weeks to 36 weeks gestation
Secondary	macrosomic baby	Fetal macrosomia has been defined birth weight greater than 4500 gm	24 hours after delivery
Secondary	Neonatal hypoglycemia	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