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NCT03117998 · ClinicalTrials.gov registry record · Phase 2
Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus
A Phase 2 study, sponsored by REMD Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
NCT03117998: Completed Phase 2 study, sponsored by REMD Biotherapeutics.
NCT03117998 is a Phase 2 study that has completed, run by REMD Biotherapeutics. The registered enrollment target is 154 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03117998, a Phase 2 study, has completed, sponsored by REMD Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
Study Summary
This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide \< 0.7 ng/mL at Screening. The study will be conducted at multiple sites in the United States. Approximately 150 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.
Primary Outcome
Change from Baseline in average daily total insulin use at Week 12
Interventions
- BIOLOGICAL Placebo Comparator
- BIOLOGICAL REMD-477
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2017-09-19 |
| Est. Completion | 2021-03-05 |
| Phase | Phase 2 |
What the finished NCT03117998 record still lists
NCT03117998 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT03117998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03117998 about?
NCT03117998 is a clinical study titled "Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus". This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily ins...
What is the current status of trial NCT03117998?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2017-09-19. Estimated completion is 2021-03-05.
What interventions are being tested in trial NCT03117998?
The interventions under investigation include: Placebo Comparator (BIOLOGICAL), REMD-477 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03117998?
This trial is sponsored by REMD Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03117998's enrollment target sits among peer trials
154 448th of 2000 higher than 1,552 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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