Clinical trial NCT02932475: Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Official title: Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes
Pregnancy
Keywords: Metformin
Glucophage
Riomet
Glumetza
Fortamet
Glucophage XR
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-10-13
Enrollment: 831
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Composite Adverse Neonatal Outcome
timeFrame: An average of 48 hours for term infants and 30 days for preterm infants
Secondary outcomes:
measure: Number of Participants With Maternal Side Effects
timeFrame: Throughout study until delivery at 40 weeks gestation
measure: Mean Infant Fat Mass
timeFrame: Within 72 hrs of birth
measure: Maternal Safety Based on Treatment Emergent Adverse Events
timeFrame: An average of 48 hours following delivery
measure: Neonatal Safety Based on Treatment Emergent Adverse Events
timeFrame: up to 28 days of life
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: University of California - San Diego
state: California
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kim Boggess, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.