Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Purpose
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.
Conditions
- Diabetes
- Pregnancy
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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 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 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Treatment |
Metformin 1000 mg twice a day |
|
Sham Comparator Placebo |
Placebo, identical to Metformin |
|
More Details
- Status
- Terminated
- Sponsor
- University of North Carolina, Chapel Hill