Efficacy and Long-Term Safety of SK-0403 as Add-on Therapy to Sulfonylurea or Biguanides in Patients With Type 2 Diabetes
Phase 3
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT2080220755
- Lead Sponsor
- Kowa Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with Type 2 Diabetes who have inadequate glycemic control on a Sulfonylurea or Biguanide Therapy
HbA1C of >=6.5%, but < 10.0% measured during the run-in period
Exclusion Criteria
Patients with Type 1 Diabetes Mellitus
Patients require insulin or oral antidiabetic drug therapy other than a Sulfonylurea or Biguanide
Patients with, or a history of, clinically significant cardiac, renal, hepatic, pulmonary, pancreatic and macrovascular disease
Patients have a known allergy or hypersensitivity to a Sulfonylurea or Biguanide
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and Safety
- Secondary Outcome Measures
Name Time Method