Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)



Status:Recruiting
Conditions:Women's Studies, Diabetes
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:18 - 45
Updated:6/21/2018
Start Date:May 25, 2017
End Date:June 30, 2021
Contact:Amber Irvins
Email:amber_irvins@med.unc.edu
Phone:(919) 843-4420

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Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy

Purpose: The objective of this proposal is to study the safety and efficacy of metformin
added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.

Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.
clinical centers

Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a
singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary
outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth
trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical
visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.


Inclusion Criteria:

- Maternal age 18-45 years

- Singleton pregnancy with no known fetal anomalies

- Gestational age between 10weeks 0 days and 20 weeks 6 days by menstrual dating
confirmed by ultrasound, or ultrasound alone

- Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or
insulin)

- Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days
gestation

- Willing to start insulin therapy and discontinue oral hypoglycemic pills other than
study pills

- Able to swallow pills

Exclusion Criteria:

- Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL

- Clinical history of lactic acidosis

- Known allergy to metformin

- Participation in another study that could affect primary outcome

- Delivery planned at non-MOMPOD study locations

- Unwillingness to use insulin treatment or follow prenatal care doctor's instructions
for insulin and blood glucose monitoring
We found this trial at
10
sites
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-1601
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Phone: 409-747-4905
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Galveston, TX
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-305-1521
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-4173
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Birmingham, Alabama 35294
Phone: 205-934-5611
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Birmingham, AL
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-8513
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Houston, Texas 77030
Phone: 713-500-6416
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Houston, TX
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Jackson, Mississippi 39216
Phone: 601-984-5396
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Jackson, MS
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-615-3817
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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San Diego, California 92093
Phone: 619-543-6906
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San Diego, CA
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