- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00678080
Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
November 1, 2018 updated by: Jerrie Refuerzo, The University of Texas Health Science Center, Houston
A Randomized, Controlled Trial of Metformin Versus Insulin in Women With Type 2 Diabetes Mellitus During Pregnancy in a Population With Severe Health Disparities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Brownsville, Texas, United States, 78520
- Valley Baptist Hospital
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Houston, Texas, United States, 77030
- Memorial Hermann Hospital
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Houston, Texas, United States, 77026
- Lyndon B Johnson Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 52 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
Metformin therapy as prescribed by their health care provider
|
Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily
Other Names:
|
Active Comparator: Insulin
Insulin as prescribed by their health care provider
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants Who Achieved a Hemoglobin A1C <7%
Time Frame: during third trimester
|
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.
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during third trimester
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The Number of Participants Who Achieved a Hemoglobin A1C <7%
Time Frame: at the time of delivery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: at the time of delivery
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at the time of delivery
|
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Number of Participants With Hypoglycemia
Time Frame: During pregnancy
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Defined as hypoglycemia as documented by neonatal chart based on health care provider description
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During pregnancy
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Number of Participants Who Failed Metformin Therapy
Time Frame: Duration of pregnancy
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Those whose glucose levels were above target range thereby needing insulin therapy
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Duration of pregnancy
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Number of Participants Who Had a Cesarean Section
Time Frame: At the time of delivery
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At the time of delivery
|
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Number of Participants With Fetus With Macrosomia
Time Frame: At the time of delivery
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At the time of delivery
|
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Number of Participants With Shoulder Dystocia
Time Frame: At the time of delivery
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At the time of delivery
|
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Number of Participants Who Had a Newborn With Respiratory Distress Syndrome
Time Frame: Neonatal period
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Neonatal period
|
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Number of Participants With Newborns Who Needed Neonatal Dextrose
Time Frame: Neonatal period
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Neonatal period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
May 8, 2008
First Submitted That Met QC Criteria
May 14, 2008
First Posted (Estimate)
May 15, 2008
Study Record Updates
Last Update Posted (Actual)
November 28, 2018
Last Update Submitted That Met QC Criteria
November 1, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-08-0015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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