TIMES 3

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCT2080223790
• Lead Sponsor: POXEL S.A./ CMIC Co., Ltd.

Brief Summary

Imeglimin significantly improved HbA1c in Japanese patients with insufficiently controlled type 2 diabetes by insulin and had a similar safety profile to placebo. The efficacy of imeglimin on top of insulin was sustained for 52 weeks. Imeglimin represents a potential new treatment option for this population as add-on to insulin therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Study Completion: 2020-01-30
• Results First Posted: 2022-01-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Main inclusion criteria:
1) Insulin treated patients with type 2 diabetes mellitus, diagnosed for at least 12 weeks
2) HbA1c >=7.5% and < 11.0%
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