An Open-label, Single-center, Drug-drug Interaction Study to Assess the Effect of SK-0403 on the Pharmacokinetics, Pharmacodynamics and Safety of Multiple Oral Administration of Miglitol in Japanese Patients With Type 2 Diabetes
Phase 3
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT2080221125
- Lead Sponsor
- SANWA KAGAKU KENKYUSHO Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
Patients with type 2 diabetes mellitus who have inadequate glycemic control by diet and/or exercise therapies
HbA1C of >= 6.5%, but < 10.0% measured during the run-in period
Exclusion Criteria
Patients with type 1 diabetes mellitus
Patients with, or a history of, clinically significant cardiac, renal, hepatic, pulmonary, pancreatic and macrovascular disease
Patients who had taken SK-0403 or miglitol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics, Pharmacodynamics and Safety
- Secondary Outcome Measures
Name Time Method