Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00678080
First received: May 8, 2008
Last updated: July 23, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


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: August 2014
Estimated Primary Completion Date: July 2014 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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.         
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

No publications provided

Responsible Party: Jerrie Refuerzo, Associate Professor - Ob/Gyn Maternal Fetal, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00678080     History of Changes
Other Study ID Numbers: HSC-MS-08-0015
Study First Received: May 8, 2008
Last Updated: July 23, 2014
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, Globin Zinc
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014