JPRN-jRCT2080221532
Unknown
Phase 2
Clinical Pharmacological study of Tofogliflozin (CSG452) in Patients with Type 2 Diabetes -Evaluation of influence by degree of kidney function
ConditionsType 2 diabetes
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type 2 diabetes
- Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Enrollment
- 40
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has been diagnosed with type 2 diabetes
- •\-normal renal function or mild renal impairment patients
- •\-HbA1c (Japanese Diabetes Society \[JDS] value) \>\=6\.5% and \<10\.0%
- •\-Body mass index (BMI) \>\=18\.5 kg/m2 and \<45\.0 kg/m2
Exclusion Criteria
- •Had the following history and/or complications within 24 weeks of tests for screening test
- •\-Acute diabetic complications such as diabetic ketoacidosis or hyperglycemic hyperosmolar coma
- •\-Acute coronary disease (acute myocardial infarction, unstable angina, etc.) or stroke
- •\-Recurrent genitourinary tract infection, defined as two or more episodes of complicated or uncomplicated cystitis or pyelonephritis
Outcomes
Primary Outcomes
Not specified
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