A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes

Poxel

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Imeglimin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951235

2012-004045-33 (EudraCT Number)

PXL008-008

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has given written informed consent
2. Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.
3. Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²
4. HbA1c criteria: ≥ 7% and ≤ 9.5%
5. Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit
6. Effective contraception for women of child bearing potential

Exclusion criteria

1. Any disease which in the investigator's opinion would exclude the subject from the study
2. Acute cardiovascular event within 3 months before randomization
3. Uncontrolled high blood pressure
4. Impairment of hepatic function
5. History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval
6. Pregnancy or lactation
7. Use of any non-permitted medication
8. Positive screen for viral hepatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 5 patient groups, including a placebo group

Imeglimin (Dose 1)

Experimental group

Treatment:

Drug: Imeglimin

Imeglimin (Dose 2)

Experimental group

Treatment:

Drug: Imeglimin

Imeglimin (Dose 3)

Experimental group

Treatment:

Drug: Imeglimin

Imeglimin (Dose 4)

Experimental group

Treatment:

Drug: Imeglimin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo