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Imeglimin

DRUG9 trials

Sponsors

Takamura Masayuki, Poxel SA, National Center for Global Health and Medicine, Japan, Mansoura University

Conditions

BioequivalenceDiabetes Mellitus, Type 2HealthyHepatic ImpairmentMetforminMitochondriaQt Interval, Variation inType 2 Diabetes Mellitus

Phase 1

Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
CompletedNCT02373150
Poxel SAType 2 Diabetes Mellitus
Start: 2015-02-28End: 2015-10-31Updated: 2017-02-10
Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects
CompletedNCT02924337
Poxel SAQt Interval, Variation in
Start: 2016-09-30End: 2016-12-31Updated: 2017-02-10
Effect of Cimetidine on the PK of Imeglimin
CompletedNCT03618316
Poxel SAHealthy
Start: 2018-06-19End: 2018-07-27Updated: 2018-08-27
Bioequivalence of Imeglimin Tablet Formulations
CompletedNCT03646331
Poxel SABioequivalence
Start: 2018-09-03End: 2018-10-02Updated: 2019-01-11
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
CompletedNCT03802786
Poxel SAHepatic Impairment
Start: 2018-11-06End: 2019-07-08Updated: 2020-08-11

Phase 2

A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
CompletedNCT01951235
Poxel SAType 2 Diabetes Mellitus
Start: 2013-01-31End: 2014-07-31Updated: 2015-08-13

Phase 4

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
RecruitingNCT05366868
National Center for Global Health and Medicine, JapanDiabetes Mellitus, Type 2
Start: 2022-05-26End: 2027-03-31Target: 567Updated: 2023-11-09
Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. Metformin Monotherapy
Not yet recruitingNCT07436182
Mansoura UniversityMetformin, Mitochondria
Start: 2026-03-01End: 2026-06-01Target: 176Updated: 2026-02-27

Unknown Phase

Effect of Imeglimin on muscle sympathetic nerve activiy in type 2 diabetes mellitus patients
RecruitingJPRN-jRCT1041220023
Takamura MasayukiType 2 diabetes Type 2 diabetes, muscle sympathetic nerve activity
Start: 2022-05-28Target: 30Updated: 2025-07-18

Related Papers

Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus.
2020-06-1811 citations