DiabetesPhase 3MOMPODNCT02932475
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
A Phase 3 study testing Metformin in people with Diabetes and Pregnancy, run by University of North Carolina, Chapel Hill at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 831 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 May 2017to 15 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Alabama
Birmingham, Alabama, 35294
University of North Carolina
Chapel Hill, North Carolina, 27599
Ohio State University
Columbus, Ohio, 43210
University of Texas Medical Branch
Galveston, Texas, 77555
University of Texas - Houston
Houston, Texas, 77030
University of Mississippi
Jackson, Mississippi, 38677
Columbia University
New York, New York, 10027
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84112
University of California - San Diego
San Diego, California, 92093
About this study
Official title: Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
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.
- Being tested
- Metformin, Placebo
- Keywords
- Metformin, Glucophage, Riomet, Glumetza, Fortamet, Glucophage XR
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glumetza, Fortamet, Glucophage, Riomet
1000 mg twice a day
PlaceboDrug
Also called Sugar pill
Delivered to match active drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Metformin 1000 mg twice a day Receives: Drug: Metformin |
| Placebo | Sham comparator | Placebo, identical to Metformin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: An average of 48 hours for term infants and 30 days for preterm infants
Secondary outcomes (4)
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
Measured: Throughout study until delivery at 40 weeks gestation
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).
Measured: Within 72 hrs of birth
Maternal Safety Based on Treatment Emergent Adverse Events
Adverse maternal outcomes.
Measured: An average of 48 hours following delivery
Neonatal Safety Based on Treatment Emergent Adverse Events
Adverse neonatal outcomes
Measured: up to 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start25 May 2017
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Why it stopped: Recommendation by the DSMB that the study be stopped for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kim Boggess, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932475
- Sponsor's protocol ID
- 15-3235
- Other IDs
- 1R01HD086139-01A1
- Acronym
- MOMPOD
- Status last verified
- Apr 2023
- First submitted
- 17 May 2016
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Patel M, Battarbee AN, Refuerzo JS, Zork N, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Boggess KA. Association Between Metformin Use in Early Gestational or Type 2 Diabetes in Pregnancy and Preterm Preeclampsia. Obstet Gynecol. 2024 Nov 1;144(5):733-739. doi: 10.1097/AOG.0000000000005720. Epub 2024 Sep 5.
PubMed 39236318Boggess KA, Valint A, Refuerzo JS, Zork N, Battarbee AN, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Young L, Marquis MA, Thomas S, Britt A, Berry D. Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2182-2190. doi: 10.1001/jama.2023.22949.
PubMed 38085312Berry 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.
PubMed 30541506
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
- ClinicalTrials.gov ID
- NCT02932475
- Acronym / sponsor ID
- MOMPOD / 15-3235
- Keywords
- Metformin, Glucophage, Riomet, Glumetza, Fortamet, Glucophage XR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recommendation by the DSMB that the study be stopped for futility
- Enrolment
- 831 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 May 2017 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: MetforminMetformin 1000 mg twice a day |
| Placebo | Sham comparator | Drug: PlaceboPlacebo, identical to Metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Glumetza, Fortamet, Glucophage, Riomet1000 mg twice a day | Drug | Treatment |
| PlaceboAlso: Sugar pillDelivered to match active drug | Drug | Placebo |
Primary outcome
Number of Participants With Composite Adverse Neonatal Outcome
Time frame: An average of 48 hours for term infants and 30 days for preterm infants
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)
4 secondary outcomes
Number of Participants With Maternal Side Effects
Time frame: Throughout study until delivery at 40 weeks gestation
Mean Infant Fat Mass
Time frame: Within 72 hrs of birth
Maternal Safety Based on Treatment Emergent Adverse Events
Time frame: An average of 48 hours following delivery
Neonatal Safety Based on Treatment Emergent Adverse Events
Time frame: up to 28 days of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39236318Patel M, Battarbee AN, Refuerzo JS, Zork N, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Boggess KA. Association Between Metformin Use in Early Gestational or Type 2 Diabetes in Pregnancy and Preterm Preeclampsia. Obstet Gynecol. 2024 Nov 1;144(5):733-739. doi: 10.1097/AOG.0000000000005720. Epub 2024 Sep 5.
- Derived from this study: PubMed 38085312Boggess KA, Valint A, Refuerzo JS, Zork N, Battarbee AN, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Young L, Marquis MA, Thomas S, Britt A, Berry D. Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2182-2190. doi: 10.1001/jama.2023.22949.
- Derived from this study: PubMed 30541506Berry 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Boggess, MD principal investigator
University of North Carolina, Chapel Hill
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Diabetes and Pregnancy, run by University of North Carolina, Chapel Hill at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Composite Adverse Neonatal Outcome (time frame: An average of 48 hours for term infants and 30 days for preterm infants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932475, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.