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Last Updated: December 14, 2019

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CLINICAL TRIALS PROFILE FOR IMEGLIMIN

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Clinical Trials for Imeglimin

Trial ID Title Status Sponsor Phase Summary
NCT01951235 A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Completed Poxel SA Phase 2 This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.
NCT02373150 Safety, Tolerability and PK of Imeglimin in Japanese Volunteers Recruiting Poxel SA Phase 1 This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.
NCT02924337 Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects Recruiting Poxel SA Phase 1 The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval
NCT03618316 Effect of Cimetidine on the PK of Imeglimin Completed Poxel SA Phase 1 The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.
NCT03646331 Bioequivalence of Imeglimin Tablet Formulations Completed Poxel SA Phase 1 This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A [reference product] and Tablet B [test product]), in at least 16 healthy Caucasian volunteers.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Imeglimin

Condition Name

Condition Name for
Intervention Trials
Type 2 Diabetes Mellitus 2
Bioequivalence 1
Qt Interval, Variation in 1
Hepatic Impairment 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Diabetes Mellitus 2
Diabetes Mellitus, Type 2 2
Liver Diseases 1
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Clinical Trial Locations for Imeglimin

Trials by Country

Trials by Country for
Location Trials
United Kingdom 4
Latvia 1
Germany 1
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Clinical Trial Progress for Imeglimin

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 1
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 3
Recruiting 3
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Clinical Trial Sponsors for Imeglimin

Sponsor Name

Sponsor Name for
Sponsor Trials
Poxel SA 6
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
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