Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

Overview[ - collapse ][ - ]

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.
ConditionPregnancy Complications
InterventionDrug: Metformin
Drug: Insulin (NPH and Regular)
PhaseN/A
SponsorThe University of Texas Health Science Center, Houston
Responsible PartyThe University of Texas Health Science Center, Houston
ClinicalTrials.gov IdentifierNCT00678080
First ReceivedMay 8, 2008
Last UpdatedJanuary 3, 2011
Last verifiedJanuary 2011

Tracking Information[ + expand ][ + ]

First Received DateMay 8, 2008
Last Updated DateJanuary 3, 2011
Start DateSeptember 2008
Estimated Primary Completion DateJune 2011
Current Primary Outcome MeasuresThe rate of achieving a hemoglobin A1C <7% [Time Frame: at the time of delivery] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin Versus Insulin in Pregnant Women With Type 2 Diabetes
Official TitleA Randomized, Controlled Trial of Metformin Versus Insulin in Women With Type 2 Diabetes Mellitus During Pregnancy in a Population With Severe Health Disparities
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.
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionPregnancy Complications
InterventionDrug: Metformin
Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily
Other Names:
GlucophaceDrug: 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
Study Arm (s)
  • Experimental: Metformin
    Metformin therapy
  • Active Comparator: Insulin
    Insulin

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment100
Estimated Completion DateJune 2011
Estimated Primary Completion DateJune 2011
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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Jerrie S Refuerzo, M.D.
713-500-6416
Jerrie.S.Refuerzo@uth.tmc.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00678080
Other Study ID NumbersHSC-MS-08-0015
Has Data Monitoring CommitteeNo
Information Provided ByThe University of Texas Health Science Center, Houston
Study SponsorThe University of Texas Health Science Center, Houston
CollaboratorsNot Provided
Investigators Principal Investigator: Jerrie S Refuerzo, M.D. The University of Texas Health Science Center, Houston
Verification DateJanuary 2011

Locations[ + expand ][ + ]

Valley Baptist Hospital
Brownsville, Texas, United States, 78520
Contact: Rose Gowen, M.D. | 956-882-5165 | Rose.M.Gowen@uth.tmc.edu
Sub-Investigator: Rose Gowen, M.D.
Recruiting
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Contact: Jerrie S Refuerzo, M.D. | 713-500-6416 | Jerrie.S.Refuerzo@uth.tmc.edu
Principal Investigator: Jerrie S Refuerzo, M.D.
Recruiting
Lyndon B Johnson Hospital
Houston, Texas, United States, 77026
Contact: Michael Lucas, M.D. | 713-566-5749 | Michael.Lucas@uth.tmc.edu
Sub-Investigator: Michael Lucas, M.D.
Recruiting