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NCT02932475 · ClinicalTrials.gov registry record · Phase 3
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
A Phase 3 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 3
- Development phase
- 831
- Enrollment target
NCT02932475 is a Phase 3 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 831 participants.
The verdict
NCT02932475, a Phase 3 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 831 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 831 participants |
| Start Date | 2017-05-25 |
| Est. Completion | 2022-06-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02932475
The ClinicalTrials.gov registry entry for NCT02932475 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 831 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02932475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02932475 about?
NCT02932475 is a clinical study titled "Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)". 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 (me...
What is the current status of trial NCT02932475?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 831 participants. The study started on 2017-05-25. Estimated completion is 2022-06-15.
What interventions are being tested in trial NCT02932475?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT02932475?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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