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

Primary Purpose

Diabetes, Pregnancy

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Metformin, Glucophage, Riomet, Glumetza, Fortamet, Glucophage XR

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Alabama
  • University of California - San Diego
  • University of Mississippi
  • Columbia University
  • University of North Carolina
  • Ohio State University
  • University of Pennsylvania
  • University of Texas Medical Branch
  • University of Texas - Houston
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment

Placebo

Arm Description

Metformin 1000 mg twice a day

Placebo, identical to Metformin

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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).
Maternal Safety Based on Treatment Emergent Adverse Events
Adverse maternal outcomes.
Neonatal Safety Based on Treatment Emergent Adverse Events
Adverse neonatal outcomes

Full Information

First Posted
May 17, 2016
Last Updated
May 31, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02932475
Brief Title
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Acronym
MOMPOD
Official Title
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Recommendation by the DSMB that the study be stopped for futility
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pregnancy
Keywords
Metformin, Glucophage, Riomet, Glumetza, Fortamet, Glucophage XR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
831 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Metformin 1000 mg twice a day
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Placebo, identical to Metformin
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glumetza, Fortamet, Glucophage, Riomet
Intervention Description
1000 mg twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Delivered to match active drug
Primary Outcome Measure Information:
Title
Number of Participants With Composite Adverse Neonatal Outcome
Description
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)
Time Frame
An average of 48 hours for term infants and 30 days for preterm infants
Secondary Outcome Measure Information:
Title
Number of Participants With Maternal Side Effects
Description
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
Time Frame
Throughout study until delivery at 40 weeks gestation
Title
Mean Infant Fat Mass
Description
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).
Time Frame
Within 72 hrs of birth
Title
Maternal Safety Based on Treatment Emergent Adverse Events
Description
Adverse maternal outcomes.
Time Frame
An average of 48 hours following delivery
Title
Neonatal Safety Based on Treatment Emergent Adverse Events
Description
Adverse neonatal outcomes
Time Frame
up to 28 days of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Boggess, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
38677
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Texas - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
30541506
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.
Results Reference
derived

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

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