Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. We hypothesize that metformin will achieve similar levels of blood sugar control compared to insulin. In doing so, metformin will prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Insulin; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history

• Treatment with diet or oral hypoglycemic agents prior to pregnancy.

• Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery.

• Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.

• Hemoglobin A1C <9%

Exclusion Criteria:

• Gestational age greater than 20 weeks

• Multiple gestations (twins or more gestations)

• Type 1 diabetes by patient history

• Known fetal chromosomal or structural defects

• Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.

• Those with a hemoglobin A1C greater than 9%.

• On insulin at the start of pregnancy