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

Phase 3TerminatedNCT02932475

University of North Carolina, Chapel Hill831 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

831

Conditions

Diabetes Pregnancy

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (10)

University of Alabama

Birmingham, Alabama, United States

University of California - San Diego

San Diego, California, United States

University of Mississippi

Jackson, Mississippi, United States

Columbia University

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Texas - Houston

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Number of Participants With Composite Adverse Neonatal Outcome

Participants with one or more of the following: * capillary blood glucose level of \< 30 mg/dL or capillary blood glucose requiring medical treatment, or * Birth trauma (umbilical cord artery pH \< 7.0 or shoulder dystocia with brachial plexus injury), or * Hyperbilirubinemia requiring phototherapy, or * Deliver \< 37 weeks' gestation, or * Miscarry, are stillborn, experience a neonatal demise, or * Large for gestational age infant (birth weight \> 90th percentile for gestational age), or * Small for gestational age infant (birth weight \< 10th percentile for gestational age) or low birth weight (\< 2500 gm)

Time frame: An average of 48 hours for term infants and 30 days for preterm infants

Secondary Outcomes

Number of Participants With Maternal Side Effects

Secondary outcome of maternal side effects were defined as: * clinically relevant hypoglycemia defined as capillary blood glucose \< 60 or \< 80 with symptoms * GI side effects defined as nausea, vomiting, diarrhea

Time frame: Throughout study until delivery at 40 weeks gestation

Mean Infant Fat Mass

Neonatal fat mass measured by skin-fold thickness (anthropometrics).The circumference of the upper limb is the circumference of the upper arm, and the circumference of the lower limb equals the mean of the circumferences measured at the midthigh and calf. The volume of the subcutaneous layer of fat covering each cylinder is estimated by multiplying the length times the circumference times the layer of fat estimated by the skinfold measures. The triceps skinfold measure is used as an estimate of the fat thickness of the limbs, and the subscapular skinfold measure approximates the fat thickness of the trunk. Total body fat is estimated by summing the volumes of fat covering each of the cylinders and multiplying by 0.9 (the density of fat).

Time frame: Within 72 hrs of birth

Maternal Safety Based on Treatment Emergent Adverse Events

Adverse maternal outcomes.

Time frame: An average of 48 hours following delivery

Neonatal Safety Based on Treatment Emergent Adverse Events

Adverse neonatal outcomes

Time frame: up to 28 days of life