Title
A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.
Phase
Phase 2Lead Sponsor
Poxel SAStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Type 2 Diabetes MellitusIntervention/Treatment
imeglimin ...Study Participants
315This 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.
Inclusion Criteria: Subject has given written informed consent Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy. Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m² HbA1c criteria: ≥ 7% and ≤ 9.5% Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit Effective contraception for women of child bearing potential Exclusion Criteria: Any disease which in the investigator's opinion would exclude the subject from the study Acute cardiovascular event within 3 months before randomization Uncontrolled high blood pressure Impairment of hepatic function History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval Pregnancy or lactation Use of any non-permitted medication Positive screen for viral hepatitis
