A Dose-Finding Study of R7201/CSG452 in Patients With Type 2 Diabetes Mellitus

A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of R7201/CSG452 in Patients With Type 2 Diabetes Mellitus

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220828

Enrollment

300

Registered

2009-08-24

Start date

2009-08-24

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

Diabetes Mellitus, Type 2

Interventions

investigational material(s) Generic name etc : R7201/CSG452 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - type 2 diabetes, diagnosed for >=3 months; - either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion criteria

Exclusion criteria: - type 1 diabetes mellitus - currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin - currently or within 6 months prior to screening treated with any PPARgamma agonist - uncontrolled hypertension - significant pre-diagnosed diabetic complications requiring treatment

Design outcomes

Primary

Measure	Time frame
Absolute change in HbA1c Time Frame: From baseline to end of treatment period	—

Secondary

Measure	Time frame
1. Absolute change in parameters of glycemic control 2. Absolute change in body weight, waist-to-hip ratio, waist circumference 3. Adverse events, laboratory parameters, vital signs 1. Time Frame: From baseline to end of treatment period 2. Time Frame: From baseline to end of treatment period 3. Time Frame: Throughout study	—

Outcome results

None listed

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