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.
Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
Completed
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.
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.
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.
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
Completed
Poxel SA
Phase 1
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate
hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be
used to determine hepatic impairment.
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