Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Ain Shams University

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Drug: Metformin; Drug: Insulin Mixtard

Study type: Interventional

Funder types: Other

Identifiers

NCT03106870

Metformin

Details and patient eligibility

About

The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

oral metformin and insulin

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Mixtard

Drug: Metformin

insulin therapy only

Active Comparator group

Description:

Intervention 'Insulin Mixtard' had included

Treatment:

Drug: Insulin Mixtard