Efficacy and Long-Term Safety of SK-0403 as Add-on Therapy to Insulin in Patients with Type 2 Diabetes
Phase 3
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-jRCT2080222199
- Lead Sponsor
- SANWA KAGAKU KENKYUSHO CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with type 2 diabetes who have inadequate glycemic control on insulin therapy
HbA1c(NGSP) of >= 6.9%, but < 11.0% measured during the run-in period
Exclusion Criteria
Patients with type 1 diabetes mellitus
Patients with severe hypoglycemia or recurrent asymptomatic hypoglycemia
Patients with, or a history of, clinically significant cardiac, renal, hepatic, pulmonary, pancreatic and macrovascular disease
Patients have a known allergy or hypersensitivity to insulin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method