Type 2 Diabetes
Conditions
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.
Interventions
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from baseline to Week 16. | Baseline, 16 weeks | Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF). |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Fasting Plasma Glucose (FPG) | Baseline, 16 weeks |
Countries
United States
Outcome results
None listed