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

Last updated: May 31, 2023
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Terminated

Phase

3

Condition

Pregnancy

Diabetic Foot Ulcers

Diabetic Kidney Disease

Treatment

Placebo

Metformin

Clinical Study ID

NCT02932475
15-3235
1R01HD086139-01A1
  • Ages 18-45
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 datingconfirmed by ultrasound, or ultrasound alone
  • Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent orinsulin)
  • Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 daysgestation
  • Willing to start insulin therapy and discontinue oral hypoglycemic pills other thanstudy pills
  • Able to swallow pills

Exclusion

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 instructionsfor insulin and blood glucose monitoring

Study Design

Total Participants: 831
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 25, 2017
Estimated Completion Date:
June 15, 2022

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of California - San Diego

    San Diego, California 92093
    United States

    Site Not Available

  • University of Mississippi

    Jackson, Mississippi 38677
    United States

    Site Not Available

  • Columbia University

    New York, New York 10027
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • University of Texas - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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