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

Diabetes Clinical Trial

— MOMPOD  

Official title:

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02932475
• Other study ID #: 15-3235
• Secondary ID: 1R01HD086139-01A
• Status: Terminated
• Phase: Phase 3
• Start date: May 25, 2017
• Est. completion date: June 15, 2022

Study information

• Verified date: April 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 831
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Pregnancy
• Pregnancy Complications

Intervention

Drug:
• Metformin
1000 mg twice a day
• Placebo
Delivered to match active drug

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Texas - Houston	Houston	Texas
United States	University of Mississippi	Jackson	Mississippi
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	University of California - San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Maternal Safety Based on Treatment Emergent Adverse Events	Adverse maternal outcomes.	An average of 48 hours following delivery
Secondary	Neonatal Safety Based on Treatment Emergent Adverse Events	Adverse neonatal outcomes	up to 28 days of life