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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diabetes, Pregnancy

In brief

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: 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.

Key facts

Study ID

NCT02932475

Run by

University of North Carolina, Chapel Hill

People needed

831

Starts

2017-05-25

Expected to finish

2022-06-15

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Maternal age 18-45 years
• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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