Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
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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) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- The rate of achieving a hemoglobin A1C <7% [ Time Frame: at the time of delivery ] [ Designated as safety issue: No ]
- 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 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin
Metformin therapy
|
Drug: Metformin
Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily
Other Name: Glucophace
|
|
Active Comparator: Insulin
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 |
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| 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 |
| United States, Texas | |
| 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. | |
| 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. | |
| Principal Investigator: | Jerrie S Refuerzo, M.D. | The University of Texas Health Science Center, Houston |
More Information
No publications provided
| Responsible Party: | Jerrie S. Refuerzo, M.D., University of Texas Health Science Center at Houston |
| ClinicalTrials.gov Identifier: | NCT00678080 History of Changes |
| Other Study ID Numbers: | HSC-MS-08-0015 |
| Study First Received: | May 8, 2008 |
| Last Updated: | January 3, 2011 |
| 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 |
Additional relevant MeSH terms:
|
Pregnancy Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013