Phase II-III Clinical Study of CSG452(RG7201) in Patients with Type 2 Diabetes
Phase 2
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-jRCT2080221312
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
Has been diagnosed with type 2 diabetes
-Has been receiving treatment with only idet and exercise therapy
-HbA1c (Japanese Diabetes Society [JDS] value) >=7.0% and <10.0%
-Body mass index (BMI) >=18.5 kg/m2 and <45.0 kg/m2
Etc.
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
-Impaired hepatic function
-Impaired renal function
Etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy(change from baseline in HbA1c(JDS))<br>Absolute change in HbA1c (JDS value) from baseline to treatment week 24 (LOCF)
- Secondary Outcome Measures
Name Time Method Efficacy(HbA1c, FPG, Body weight)<br>Absolute change in various parameters from baseline to treatment week 24, and percentage of subjects who reached the target HbA1c levels at treatment week 24