Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
NCT ID: NCT02932475
Last Updated: 2023-06-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
831 participants
INTERVENTIONAL
2017-05-25
2022-06-15
Brief Summary
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Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers
Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded 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, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
Metformin 1000 mg twice a day
Metformin
1000 mg twice a day
Placebo
Placebo, identical to Metformin
Placebo
Delivered to match active drug
Interventions
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Metformin
1000 mg twice a day
Placebo
Delivered to match active drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy with no known fetal anomalies
* Gestational age between 10weeks 0 days and 22 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 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
18 Years
45 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Kim Boggess, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California - San Diego
San Diego, California, United States
University of Mississippi
Jackson, Mississippi, United States
Columbia University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Boggess KA, Valint A, Refuerzo JS, Zork N, Battarbee AN, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Young L, Marquis MA, Thomas S, Britt A, Berry D. Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2182-2190. doi: 10.1001/jama.2023.22949.
Berry DC, Thomas SD, Dorman KF, Ivins AR, de Los Angeles Abreu M, Young L, Boggess K. Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study. BMC Pregnancy Childbirth. 2018 Dec 12;18(1):488. doi: 10.1186/s12884-018-2108-3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-3235
Identifier Type: -
Identifier Source: org_study_id
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