Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

NCT ID: NCT00678080

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-08-31

Brief 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.

Detailed Description

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. Currently, insulin is the primary medication used to treat pregnant women with T2DM. However, it is administered by injection several times a day and compliance is low in health disparity populations with high rates of obesity and diabetes. Insulin also has the potential to lead to dangerously low blood sugars. Metformin is a medication than can be administered as pills and is not associated with dangerous low blood sugars. In addition, this insulin sensitizer is the medication of choice for women who are obese and have T2DM outside of pregnancy. 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. The aims of this study is to determine if in pregnant women with T2DM, metformin achieves similar glycemic control, and similar maternal and neonatal outcomes when compared to insulin. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

Conditions

Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Metformin therapy as prescribed by their health care provider

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily

Insulin

Insulin as prescribed by their health care provider

Group Type: ACTIVE_COMPARATOR

Insulin (NPH and Regular)

Intervention Type: DRUG

Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day

Interventions

Metformin

Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily

Intervention Type: DRUG

Insulin (NPH and Regular)

Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day

Intervention Type: DRUG

Other Intervention Names

Glucophage

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Jerrie Refuerzo

Associate Professor - Ob/Gyn Maternal Fetal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerrie S Refuerzo, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Valley Baptist Hospital

Brownsville, Texas, United States

Lyndon B Johnson Hospital

Houston, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-08-0015

Identifier Type: -

Identifier Source: org_study_id