Clinical trial NCT00678080: Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Keywords: Type 2 diabetes mellitus
Pregnancy
Metformin
Insulin
Pregnant women
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Number of Participants Who Achieved a Hemoglobin A1C <7%
timeFrame: during third trimester
measure: The Number of Participants Who Achieved a Hemoglobin A1C <7%
timeFrame: at the time of delivery
Secondary outcomes:
measure: Body Mass Index
timeFrame: at the time of delivery
measure: Number of Participants With Hypoglycemia
timeFrame: During pregnancy
measure: Number of Participants Who Failed Metformin Therapy
timeFrame: Duration of pregnancy
measure: Number of Participants Who Had a Cesarean Section
timeFrame: At the time of delivery
measure: Number of Participants With Fetus With Macrosomia
timeFrame: At the time of delivery
measure: Number of Participants With Shoulder Dystocia
timeFrame: At the time of delivery
measure: Number of Participants Who Had a Newborn With Respiratory Distress Syndrome
timeFrame: Neonatal period
measure: Number of Participants With Newborns Who Needed Neonatal Dextrose
timeFrame: Neonatal period
Other outcomes:
Locations:
city: Brownsville
country: United States
facility: Valley Baptist Hospital
state: Texas
city: Houston
country: United States
facility: Lyndon B Johnson Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jerrie S Refuerzo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: