Status:
COMPLETED
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
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive
- Screening HbA1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies \[DPP-4 inhibitors and GLP-1 analogues\]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose.
- No antidiabetic medication other than metformin for 3 months prior to randomization.
- Fasting plasma glucose less than 270 mg/dL (15 mmol/L) at screening.
- Body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening.
Exclusion
- History of type 1 diabetes.
- Received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit.
- Use of 3 or more oral antidiabetic medications at the time of the screening visit.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT01169090
Start Date
July 1 2010
End Date
August 1 2011
Last Update
August 17 2011
Active Locations (40)
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Birmingham, Alabama, United States
2
Huntsville, Alabama, United States
3
Muscle Shoals, Alabama, United States
4
Phoenix, Arizona, United States