JPRN-jRCT2080221200
Unknown
Phase 3
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 Metformin in Japanese Patients With Type 2 Diabetes
ConditionsType 2 diabetes mellitus
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Type 2 diabetes mellitus
- Sponsor
- SANWA KAGAKU KENKYUSHO Co., Ltd.
- Enrollment
- 18
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 metformin
Outcomes
Primary Outcomes
Not specified
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