Phase III Long-Term Combination Therapy of CSG452(RG7201) in Patients with Type 2 Diabetes
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-jRCT2080221315
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 565
Has been diagnosed with type 2 diabetes
-Has been receiving treatment with one of oral hypoglycaemic drugs at an approved dosing regimen in addition to diet and exercise therapy, and there has been no change in the prescription
-HbA1c (Japanese Diabetes Society [JDS] value) >=6.5% and <10.0%
-Body mass index (BMI) >=18.5 kg/m2 and <45.0 kg/m2
Etc.
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 Safety
- Secondary Outcome Measures
Name Time Method Efficacy(HbA1c(JDS), FPG)<br>Absolute change in parameters such as HbA1c (JDS value) from baseline to treatment week 52