Phase II-III Clinical Study of CSG452(RG7201) in Patients with Type 2 Diabetes

Phase II-III Clinical Study of CSG452(RG7201) in Patients with Type 2 Diabetes. -Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Comparative Study in Monotherapy -

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221312

Enrollment

220

Registered

2010-11-17

Start date

2010-11-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

investigational material(s) Generic name etc : CSG452(RG7201) INN of investigational material : tofogliflozin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

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 =18.5 kg/m2 and <45.0 kg/m2 Etc.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Efficacy(change from baseline in HbA1c(JDS)) Absolute change in HbA1c (JDS value) from baseline to treatment week 24 (LOCF)	—

Secondary

Measure	Time frame
Efficacy(HbA1c, FPG, Body weight) 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	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026