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
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Houston, Texas 77030
Phone: 713-500-6416
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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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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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Chapel Hill, NC
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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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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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