Phase III Long-Term Monotherapy of CSG452(RG7201) in Patients with Type 2 Diabetes

Phase III Long-Term Clinical Study of CSG452(RG7201) in Patients with Type 2 Diabetes. -Long-term Study in Monotherapy -

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221314

Enrollment

192

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 diet and exercise therapy -HbA1c (Japanese Diabetes Society [JDS] value) >=6.5% 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
Safety	—

Secondary

Measure	Time frame
Efficacy(HbA1c(JDS), FPG) Absolute change in parameters such as HbA1c (JDS value) from baseline to treatment week 52	—

Outcome results

None listed

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