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

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy

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 Overview

• Status: Terminated
• Conditions: Diabetes; Pregnancy
• Intervention / Treatment: Drug: Metformin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 831
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • San Diego, California, United States, 92093
      • University of California - San Diego
  • Mississippi
    • Jackson, Mississippi, United States, 38677
      • University of Mississippi
  • New York
    • New York, New York, United States, 10027
      • Columbia University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • University of Texas - Houston
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; Metformin 1000 mg twice a day	Drug: Metformin; 1000 mg twice a day; Other Names: Glucophage; Glumetza; Fortamet; Riomet
Sham Comparator: Placebo; Placebo, identical to Metformin	Drug: Placebo; Delivered to match active drug; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	An average of 48 hours for term infants and 30 days for preterm infants

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Within 72 hrs of birth
Maternal Safety Based on Treatment Emergent Adverse Events	Adverse maternal outcomes.	An average of 48 hours following delivery
Neonatal Safety Based on Treatment Emergent Adverse Events	Adverse neonatal outcomes	up to 28 days of life

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Kim Boggess, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Berry DC, Thomas SD, Dorman KF, Ivins AR, de Los Angeles Abreu M, Young L, Boggess K. Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study. BMC Pregnancy Childbirth. 2018 Dec 12;18(1):488. doi: 10.1186/s12884-018-2108-3.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimated): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Metformin; Glucophage; Glucophage XR; Riomet; Glumetza; Fortamet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Pregnancy Complications; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 15-3235; 1R01HD086139-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No