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

University of North Carolina (UNC)

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Pregnancy

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02932475

1R01HD086139-01A1 (U.S. NIH Grant/Contract)

15-3235

Details and patient eligibility

About

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.

Enrollment: 831 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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831 participants in 2 patient groups

Treatment

Active Comparator group

Description:

Metformin 1000 mg twice a day

Treatment:

Drug: Metformin

Placebo

Sham Comparator group

Description:

Placebo, identical to Metformin

Treatment:

Drug: Placebo