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NCT02581657 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Safety, Tolerability, PK and PD Response of PE0139 Injection in Adult Subjects With T2DM
A Phase 2 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT02581657: Completed Phase 2 study, sponsored by PhaseBio Pharmaceuticals.
NCT02581657 is a Phase 2 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581657, a Phase 2 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study is a randomized, double-blind (Investigator and study subject), placebo controlled multiple dose sequential ascending dose study that will enroll up to 47 male and female subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts.
Primary Outcome
To evaluate the safety and tolerability (as assessed by incidence and severity of AEs, hypoglycemia and changes from baseline in vital signs, ECGs and safety laboratory parameters) of multiple ascending doses of PE0139 administered as once weekly injection for 6 weeks in adults with T2DM.
Interventions
- DRUG Placebo Injection
- DRUG PE0139 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT02581657 record still lists
NCT02581657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Injection is the first listed.
NCT02581657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02581657 about?
NCT02581657 is a clinical study titled "Study to Assess the Safety, Tolerability, PK and PD Response of PE0139 Injection in Adult Subjects With T2DM". This study is a randomized, double-blind (Investigator and study subject), placebo controlled multiple dose sequential ascending dose study that will enroll up to 47 male and female subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts.
What is the current status of trial NCT02581657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2015-10. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02581657?
The interventions under investigation include: Placebo Injection (DRUG), PE0139 Injection (DRUG).
Who is sponsoring clinical trial NCT02581657?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02581657's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 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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