Summary

for females ages 18-45 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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: 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.

Official Title

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy

Keywords

Diabetes Pregnancy Diabetes Mellitus Pregnancy Complications Metformin

Eligibility

You can join if…

Open to females ages 18-45

  • 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

You CAN'T join 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

Locations

  • University of California - San Diego not yet accepting patients
    San Diego California 92093 United States
  • University of Utah not yet accepting patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of North Carolina, Chapel Hill
ID
NCT02932475
Phase
Phase 3
Study Type
Interventional
Last Updated