Clareo Health | 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 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kowa Research Institute, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
