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NCT06445946 · ClinicalTrials.gov registry record · Phase 4
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
A Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,572
- Enrollment target
- 20
- Study locations
NCT06445946 is a Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 1,572 participants, above the 239-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (558% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT06445946, a Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,572 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Insulin
Study Locations (20)
Massachusetts
- Tufts University - Boston
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Texas
- University of Texas Austin - Austin
- Austin Maternal Fetal Medicine - Austin
- University of Texas Health Science Center - Houston
California
- Cedars Sinai Medical Center - Los Angeles
- University of California San Francisco - San Francisco
Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine - Columbus
- Premier Health - Miami Valley Hospital - Dayton
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
Alabama
- University of Alabama - Tuscaloosa
Florida
- University of South Florida - Tampa
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,572 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2030-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06445946
The ClinicalTrials.gov registry entry for NCT06445946 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 1,572 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 239-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (558% higher). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy, High Risk appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.
NCT06445946 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Massachusetts, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06445946 about?
NCT06445946 is a clinical study titled "DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes". This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable ins...
What is the current status of trial NCT06445946?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,572 participants. The study started on 2024-08-01. Estimated completion is 2030-12.
What conditions does trial NCT06445946 study?
This clinical trial studies the following conditions: Pregnancy, High Risk, Gestational Diabetes Mellitus.
What interventions are being tested in trial NCT06445946?
The interventions under investigation include: Metformin (DRUG), Insulin (DRUG).
Who is sponsoring clinical trial NCT06445946?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06445946 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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