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NCT03651531 · ClinicalTrials.gov registry record · Phase 3
Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus
A Phase 3 study, sponsored by Women and Infants Hospital of Rhode Island.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT03651531: Clinical Trial Phase 3 study, sponsored by Women and Infants Hospital of Rhode Island.
NCT03651531 is a Phase 3 study that was terminated before completion, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03651531, a Phase 3 study, was terminated before completion, sponsored by Women and Infants Hospital of Rhode Island.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM). The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.
Primary Outcome
Hgb A1c test
Interventions
- DRUG Metformin
- DRUG Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2019-07-30 |
| Phase | Phase 3 |
Why NCT03651531 stopped before completion
NCT03651531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT03651531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03651531 about?
NCT03651531 is a clinical study titled "Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus". This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM). The investigator's hypothesis is that the combination of metformin and insulin will be superior...
What is the current status of trial NCT03651531?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2018-01-03. Estimated completion is 2019-07-30.
What interventions are being tested in trial NCT03651531?
The interventions under investigation include: Metformin (DRUG), Insulin (DRUG).
Who is sponsoring clinical trial NCT03651531?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03651531's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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