A dose-ranging study of imeglimin in Japanese type 2 diabetic subjects

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223032

Enrollment

304

Registered

2015-12-01

Start date

2015-12-01

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 Mellitus

Interventions

investigational material(s) Generic name etc : PXL008 INN of investigational material : Imeglimin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational mate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main inclusion criteria: 1) Patients with type 2 diabetes mellitus, diagnosed for at least 3 months 2) Body mass index (BMI) >= 18.5 3) HbA1c >= 7.0% and < 10.0%

Exclusion criteria

Exclusion criteria: Main exclusion criteria: 1) Patients with type 1 diabetes mellitus 2) History of ketoacidosis or lactic acidosis 3) Acute clinically significant cardiovascular event within 6 months (myocardial infarction, stroke) 4) Uncontrolled high blood pressure 5) Impairment of hepatic function

Design outcomes

Primary

Measure	Time frame
HbA1c To determine the change in HbA1c from baseline after 24 weeks of imeglimin treatment	—

Secondary

Measure	Time frame
HbA1c To assess the optimal dose of imeglimin in Japanese population	—

Outcome results

None listed

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