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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02932475
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 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
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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 Name: Sugar pill




Primary Outcome Measures :
  1. Composite adverse neonatal outcome [ Time Frame: 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 :
  1. Maternal safety [ Time Frame: 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


  2. Infant fat mass [ Time Frame: Within 72 hrs of birth ]
    Percent neonatal fat mass measured by skin-fold thickness (anthropometrics) measured at flank, biceps and sub scapular

  3. Maternal side effects [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932475


Contacts
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Contact: Amber Irvins (919) 843-4420 amber_irvins@med.unc.edu
Contact: Karen Dorman (984) 974-9012 kdorman@med.unc.edu

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Lori Harper, MD    205-934-5611    lmharper@uabmc.edu   
United States, California
University of California - San Diego Recruiting
San Diego, California, United States, 92093
Contact: Gladys Ramos, MD    619-543-6906    gramos@ucsd.edu   
United States, Mississippi
University of Mississippi Recruiting
Jackson, Mississippi, United States, 38677
Contact: Kedra Wallace, MD    601-984-5396    kwallace2@umc.edu   
United States, New York
Columbia University Recruiting
New York, New York, United States, 10027
Contact: Ronald Wapner, MD    212-305-1521    rw2191@columbia.edu   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kim Boggess, MD    919-966-1601    kboggess@med.unc.edu   
Contact: Karen Dorman    984-974-9012    kdorman@med.unc.edu   
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Mark Landon, MD    614-293-8513    mark.landon@osumc.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Celeste Durswald, MD    215-615-3817    celeste.durnwald@uphs.upenn.edu   
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Gayle Olson, MD    409-747-4905    golson@utmb.edu   
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Jeffie Refuerzo    713-500-6416    jerrie.s.refuerzo@uth.tmc.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Michael Varner    801-581-4173    michael.varner@hsc.utah.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Kim Boggess, MD University of North Carolina, Chapel Hill
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02932475    
Other Study ID Numbers: 15-3235
1R01HD086139-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Metformin
Glucophage
Riomet
Glumetza
Fortamet
Glucophage XR
Additional relevant MeSH terms:
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Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs