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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Terminated

CT.gov ID

NCT02932475

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

831

Enrollment

Locations

Arms

53.5

Actual Duration (Months)

83.1

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Pregnancy	Drug: Metformin Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

831 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy

Actual Study Start Date :

May 25, 2017

Actual Primary Completion Date :

Nov 8, 2021

Actual Study Completion Date :

Nov 8, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Treatment

Metformin 1000 mg twice a day

Drug: Metformin

1000 mg twice a day

Other Names:

Glumetza

Fortamet

Glucophage

Riomet

Sham Comparator: Placebo

Placebo, identical to Metformin

Drug: Placebo

Delivered to match active drug

Other Names:

Sugar pill

Outcome Measures

Primary Outcome Measures

Composite adverse neonatal outcome [An average of 48 hours for term infants and 30 days for preterm infants]
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)

Secondary Outcome Measures

Maternal safety [An average of 48 hours following delivery]
Adverse maternal outcomes, e.g. death, diabetic ketoacidosis, hypoglycemia requiring medical therapy, ICU admission/intubation, renal failure • Maternal obstetrical complications, e.g. placental abruption, preeclampsia
Infant fat mass [Within 72 hrs of birth]
Percent neonatal fat mass measured by skin-fold thickness (anthropometrics) measured at flank, biceps and sub scapular
Maternal side effects [Throughout study until delivery at 40 weeks gestation]
Maternal clinically relevant hypoglycemia defined as capillary blood glucose < 60 or < 80 with symptoms • Maternal side effects such as nausea, vomiting, diarrhea that cannot be managed with oral medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	University of California - San Diego	San Diego	California	United States	92093
3	University of Mississippi	Jackson	Mississippi	United States	38677
4	Columbia University	New York	New York	United States	10027
5	University of North Carolina	Chapel Hill	North Carolina	United States	27599
6	Ohio State University	Columbus	Ohio	United States	43210
7	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
8	University of Texas Medical Branch	Galveston	Texas	United States	77555
9	University of Texas - Houston	Houston	Texas	United States	77030
10	University of Utah	Salt Lake City	Utah	United States	84112