TIMES 2

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCT2080223726
• Lead Sponsor: POXEL S.A./ CMIC Co., Ltd.

Brief Summary

Imeglimin provides well-tolerated long-term safety and efficacy in both mono- and oral combination therapy in Japanese patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-22
• Study Completion: 2020-02-27
• Results First Posted: 2021-12-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 714

Inclusion Criteria

Main inclusion criteria:

1) Patients with type 2 diabetes mellitus, diagnosed for at least 12 weeks
2) HbA1c >=7.0% and < 10.0%

3) Patients with type 2 diabetes mellitus, diagnosed for at least 24 weeks
4) HbA1c >=7.5% and < 10.5%

5) Body Mass Index (BMI) >= 18.5

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