Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
Information source: The University of Texas Health Science Center, Houston
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy Complications
Intervention: Metformin (Drug); Insulin (NPH and Regular) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s):
Jerrie S Refuerzo, M.D., Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Overall contact:
Jerrie S Refuerzo, M.D., Phone: 713-500-6416, Email: Jerrie.S.Refuerzo@uth.tmc.edu
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.
Clinical Details
Official title: A Randomized, Controlled Trial of Metformin Versus Insulin in Women With Type 2 Diabetes Mellitus During Pregnancy in a Population With Severe Health Disparities
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The rate of achieving a hemoglobin A1C <7%
Secondary outcome: Body mass indexHypoglycemia Failed metformin therapy Cesarean section rate Rate of macrosomia Rate of shoulder dystocia Respiratory distress syndrome of the newborn Need for neonatal dextrose
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 52 Years.
Gender(s): Female.
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
Locations and Contacts
Jerrie S Refuerzo, M.D., Phone: 713-500-6416, Email: Jerrie.S.Refuerzo@uth.tmc.edu
Valley Baptist Hospital, Brownsville, Texas 78520, United States; Recruiting
Rose Gowen, M.D., Phone: 956-882-5165, Email: Rose.M.Gowen@uth.tmc.edu
Elizabeth Braunstein, R.N., Phone: +1 (956) 882-6677, Email: Elizabeth.Braunstein@uth.tmc.edu
Rose Gowen, M.D., Sub-Investigator
Memorial Hermann Hospital, Houston, Texas 77030, United States; Recruiting
Jerrie S Refuerzo, M.D., Phone: 713-500-6416, Email: Jerrie.S.Refuerzo@uth.tmc.edu
Felicia Ortiz, R.N., Phone: 713-704-6501, Email: Felicia.Ortiz@uth.tmc.edu
Jerrie S Refuerzo, M.D., Principal Investigator
Lyndon B Johnson Hospital, Houston, Texas 77026, United States; Recruiting
Michael Lucas, M.D., Phone: 713-566-5749, Email: Michael.Lucas@uth.tmc.edu
Felicia Ortiz, R.N., Phone: 713-704-6501, Email: Felicia.Ortiz@uth.tmc.edu
Michael Lucas, M.D., Sub-Investigator
Additional Information
Starting date: September 2008
Last updated: June 1, 2010
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