Summary

Eligibility
for females ages 18-45 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Gladys Ramos, MD
Photo of Gladys Ramos
Gladys Ramos

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: 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.

Official Title

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy

Keywords

Diabetes Pregnancy Metformin Glucophage Riomet Glumetza Fortamet Glucophage XR Pregnancy Complications Diabetes Mellitus

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 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 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 accepting new patients
    San Diego California 92093 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84112 United States

Lead Scientist at UCSD

  • Gladys Ramos, MD
    Clinical Professor, Ob/Gyn & Reproductive sciences. Authored (or co-authored) 33 research publications.

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