TIMES 1

A phase III, double-blind, placebo-controlled, monotherapy study of imeglimin (TIMES 1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223713

Enrollment

212

Registered

2017-11-13

Start date

2017-12-26

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 12 weeks 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, diabetes that is a result of pancreatic injury, or secondary forms of diabetes 2) History of diabetic ketoacidosis or hyperosmolar non-ketotic coma 3) Cardiovascular or cerebrovascular disease within 24 weeks (myocardial infarction, stroke, unstable angina etc.) 4) Uncontrolled high blood pressure 5) Severe impairment of hepatic function

Design outcomes

Primary

Measure	Time frame
efficacy HbA1c To assess the change in HbA1c from baseline after 24 weeks of imeglimin treatment compared to placebo	—

Secondary

Measure	Time frame
efficacy safety Fasting Blood Glucose (FPG) To assess the change in HbA1c from baseline after 24 weeks of imeglimin treatment compared to placebo	—

Countries

Japan

Outcome results

None listed

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