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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-17
• Last Update Posted: 17 October 2023

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