Overview

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

Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Metformin
Criteria
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