TIMES 1

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCT2080223713
• Lead Sponsor: POXEL S.A./ CMIC Co., Ltd.

Brief Summary

Imeglimin significantly improved HbA1c in Japanese patients with type 2 diabetes compared with placebo and had a similar safety profile to placebo. Imeglimin represents a potential new treatment option for this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-13
• Study Completion: 2019-06-06
• Results First Posted: 2021-02-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 213

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>HbA1c<br>To assess the change in HbA1c from baseline after 24 weeks of imeglimin treatment compared to placebo

Secondary Outcome Measures

Name	Time	Method
efficacy<br>safety<br>Fasting Blood Glucose (FPG)<br>To assess the change in HbA1c from baseline after 24 weeks of imeglimin treatment compared to placebo