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
- Conditions
- Health Condition 1: null- Type 2 Diabetes
- Registration Number
- CTRI/2012/02/002409
- Lead Sponsor
- Kowa Research Institute Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 620
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method