Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

Pregnancy Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678080
• Other study ID #: HSC-MS-08-0015
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Pregnancy Complications

Intervention

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

Locations

Country	Name	City	State
United States	Valley Baptist Hospital	Brownsville	Texas
United States	Lyndon B Johnson Hospital	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Who Achieved a Hemoglobin A1C <7%	The hemoglobin A1c level is an indicator of glycemic control—it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.	during third trimester
Primary	The Number of Participants Who Achieved a Hemoglobin A1C <7%	The hemoglobin A1c level is an indicator of glycemic control—it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.	at the time of delivery
Secondary	Body Mass Index		at the time of delivery
Secondary	Number of Participants With Hypoglycemia	Defined as hypoglycemia as documented by neonatal chart based on health care provider description	During pregnancy
Secondary	Number of Participants Who Failed Metformin Therapy	Those whose glucose levels were above target range thereby needing insulin therapy	Duration of pregnancy
Secondary	Number of Participants Who Had a Cesarean Section		At the time of delivery
Secondary	Number of Participants With Fetus With Macrosomia		At the time of delivery
Secondary	Number of Participants With Shoulder Dystocia		At the time of delivery
Secondary	Number of Participants Who Had a Newborn With Respiratory Distress Syndrome		Neonatal period
Secondary	Number of Participants With Newborns Who Needed Neonatal Dextrose		Neonatal period