Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes - Full Text View

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00678080

Purpose

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.

Condition	Intervention
Pregnancy Complications	Drug: Metformin Drug: Insulin (NPH and Regular)

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Metformin Metformin hydrochloride Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

The rate of achieving a hemoglobin A1C <7% [ Time Frame: at the time of delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body mass index [ Time Frame: At delivery ] [ Designated as safety issue: No ]
Hypoglycemia [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]
Failed metformin therapy [ Time Frame: Duration of pregnancy ] [ Designated as safety issue: No ]
Cesarean section rate [ Time Frame: At the time of delivery ] [ Designated as safety issue: No ]
Rate of macrosomia [ Time Frame: At the time of delivery ] [ Designated as safety issue: No ]
Rate of shoulder dystocia [ Time Frame: At the time of delivery ] [ Designated as safety issue: No ]
Respiratory distress syndrome of the newborn [ Time Frame: Neonatal period ] [ Designated as safety issue: No ]
Need for neonatal dextrose [ Time Frame: Neonatal period ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Metformin: Experimental Metformin therapy	Drug: Metformin Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily
Insulin: Active Comparator Insulin	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

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

Ages Eligible for Study:	18 Years to 52 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678080

Contacts

Contact: Jerrie S Refuerzo, M.D.	713-500-6416	Jerrie.S.Refuerzo@uth.tmc.edu
Contact: Felicia Ortiz, R.N.	713-704-6501	Felicia.Ortiz@uth.tmc.edu

Locations

United States, Texas
Memorial Hermann Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Jerrie S Refuerzo, M.D. 713-500-6416 Jerrie.S.Refuerzo@uth.tmc.edu
Contact: Felicia Ortiz, R.N. 713-704-6501 Felicia.Ortiz@uth.tmc.edu
Principal Investigator: Jerrie S Refuerzo, M.D.
Lyndon B Johnson Hospital	Recruiting
Houston, Texas, United States, 77026
Contact: Michael Lucas, M.D. 713-566-5749 Michael.Lucas@uth.tmc.edu
Contact: Felicia Ortiz, R.N. 713-704-6501 Felicia.Ortiz@uth.tmc.edu
Sub-Investigator: Michael Lucas, M.D.
Valley Baptist Hospital	Recruiting
Brownsville, Texas, United States, 78520
Contact: Rose Gowen, M.D. 956-882-5165 Rose.M.Gowen@uth.tmc.edu
Contact: Elizabeth Braunstein, R.N. +1 (956) 882-6677 Elizabeth.Braunstein@uth.tmc.edu
Sub-Investigator: Rose Gowen, M.D.

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

Jerrie S Refuerzo, M.D.

The University of Texas Health Science Center, Houston

More Information

Responsible Party:	University of Texas Health Science Center at Houston ( Jerrie S. Refuerzo, M.D. )
Study ID Numbers:	HSC-MS-08-0015
Study First Received:	May 8, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00678080
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Type 2 diabetes mellitus
Pregnancy
Metformin
Insulin
Pregnant women

Study placed in the following topic categories:

Metabolic Diseases
Pregnancy Complications
Metformin
Diabetes Mellitus, Type 2
Benzocaine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009