Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

NCT ID: NCT03106870

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

oral metformin and insulin

Intervention 'Insulin Mixtard' and Intervention 'metformin' had included

Group Type: ACTIVE_COMPARATOR

Insulin Mixtard

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

insulin therapy only

Intervention 'Insulin Mixtard' had included

Group Type: ACTIVE_COMPARATOR

Insulin Mixtard

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

insulin mixtures; Metformin Hydrocloride

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Mohamed Abdelrahman

Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Metformin

Identifier Type: -

Identifier Source: org_study_id