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NCT01835730 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
A Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01835730: Completed Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
NCT01835730 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01835730, a Phase 1 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).
Primary Outcome
Safety will be evaluated by analyses of the change from baseline in vital signs.
Interventions
- DRUG Placebo
- DRUG PE0139 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01835730 record still lists
NCT01835730 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01835730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01835730 about?
NCT01835730 is a clinical study titled "Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus". This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).
What is the current status of trial NCT01835730?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2013-04. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01835730?
The interventions under investigation include: Placebo (DRUG), PE0139 Injection (DRUG).
Who is sponsoring clinical trial NCT01835730?
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 NCT01835730's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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