NCT02932475

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
831

participants targeted

Target at P75+ for phase_3 diabetes

Timeline
Completed

Started May 2017

Longer than P75 for phase_3 diabetes

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

May 25, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 24, 2023

Completed
Last Updated

June 26, 2023

Status Verified

April 1, 2023

Enrollment Period

5.1 years

First QC Date

May 17, 2016

Results QC Date

April 27, 2023

Last Update Submit

May 31, 2023

Conditions

DiabetesPregnancy

Keywords

MetforminGlucophageRiometGlumetzaFortametGlucophage XR

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of Participants With Maternal Side Effects

    Throughout study until delivery at 40 weeks gestation

  • Mean Infant Fat Mass

    Within 72 hrs of birth

  • Maternal Safety Based on Treatment Emergent Adverse Events

    An average of 48 hours following delivery

  • Neonatal Safety Based on Treatment Emergent Adverse Events

    up to 28 days of life

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Metformin 1000 mg twice a day

Drug: Metformin

Placebo

SHAM COMPARATOR

Placebo, identical to Metformin

Drug: Placebo

Interventions

MetforminDRUG

1000 mg twice a day

Also known as: Glumetza, Fortamet, Glucophage, Riomet
Treatment
PlaceboDRUG

Delivered to match active drug

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California - San Diego

San Diego, California, 92093, United States

Location

University of Mississippi

Jackson, Mississippi, 38677, United States

Location

Columbia University

New York, New York, 10027, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

  • Boggess KA, Valint A, Refuerzo JS, Zork N, Battarbee AN, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Young L, Marquis MA, Thomas S, Britt A, Berry D. Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2182-2190. doi: 10.1001/jama.2023.22949.

    PMID: 38085312DERIVED

  • 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.

    PMID: 30541506DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

MetforminSugars

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsCarbohydrates

Results Point of Contact

Title
Kim Boggess, MD
Organization
University of North Carolina at Chapel Hill
kboggess@med.unc.edu
919-966-1601

Study Officials

  • Kim Boggess, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

October 13, 2016

Study Start

May 25, 2017

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

June 26, 2023

Results First Posted

May 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Locations

US(10)