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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 is a Phase 2 study that has completed, run by REMD Biotherapeutics. The registered enrollment target is 154 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03117998
The ClinicalTrials.gov registry entry for NCT03117998 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is REMD Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT03117998 reports 0 study locations.
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.
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