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NCT01169090 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
A Phase 2 study, sponsored by Kowa Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 620
- Enrollment target
NCT01169090: Completed Phase 2 study, sponsored by Kowa Research Institute.
NCT01169090 is a Phase 2 study that has completed, run by Kowa Research Institute. The registered enrollment target is 620 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (366% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01169090, a Phase 2 study, has completed, sponsored by Kowa Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 620 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.
Primary Outcome
Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).
Interventions
- DRUG Placebo
- DRUG Sitagliptin
- DRUG SK-0403
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01169090 record still lists
NCT01169090 is an interventional study that assigns participants to a tested intervention. The registered 620 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 (366% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01169090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01169090 about?
NCT01169090 is a clinical study titled "A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy". The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.
What is the current status of trial NCT01169090?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 620 participants. The study started on 2010-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01169090?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG), SK-0403 (DRUG).
Who is sponsoring clinical trial NCT01169090?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01169090's enrollment target sits among peer trials
620 52nd of 2000 higher than 1,948 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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