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
Public ClinicalTrials.gov record NCT01169090. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Phase 2 Dose Finding 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
Study identification
- NCT ID
- NCT01169090
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Kowa Research Institute, Inc.
- Industry
- Enrollment
- 620 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- SK-0403 Drug
- Sitagliptin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- Jun 30, 2011
- Completion
- Jul 31, 2011
- Last update posted
- Aug 16, 2011
2010 – 2011
United States locations
- U.S. sites
- 40
- U.S. states
- 19
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Huntsville | Alabama | — | — |
| Not listed | Muscle Shoals | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Encinitas | California | — | — |
| Not listed | Huntington Park | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | San Mateo | California | — | — |
| Not listed | Spring Valley | California | — | — |
| Not listed | Walnut Creek | California | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Palm Harbour | Florida | — | — |
| Not listed | Pembroke Pines | Florida | — | — |
| Not listed | Honolulu | Hawaii | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Lexington | Kentucky | — | — |
| Not listed | Paducah | Kentucky | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Saint Paul | Minnesota | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Greenville | North Carolina | — | — |
| Not listed | Statesville | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Marion | Ohio | — | — |
| Not listed | Mount Giliad | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Eugene | Oregon | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Beaver | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Greensboro | South Carolina | — | — |
| Not listed | Corpus Christi | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Sandy City | Utah | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01169090, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 16, 2011 · Synced May 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01169090 live on ClinicalTrials.gov.