Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Gestational Diabetes

Treatments: Other: Assessment of weight gain; Drug: Metformin; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03841591

MatWt-GDM

Details and patient eligibility

About

Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.

This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.

Enrollment: 124 patients

Sex: Female

Ages: 19 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged (19-35) years
• BMI 18-30 kg/m2
• Gestational age >24 weeks
• Singleton pregnancy
• Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG > 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.

Exclusion criteria

• Pregnant women with preexisting diabetes mellitus
• Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
• Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
• Fetal anomalies identified on ultrasound prior to initiation of therapy.
• Patients who refused to participate

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Insulin Group

Active Comparator group

Description:

This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.

Treatment:

Other: Assessment of weight gain

Drug: Insulin

Metformin Group

Active Comparator group

Description:

This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.

Treatment:

Other: Assessment of weight gain

Drug: Metformin