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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Imeglimin; Drug: Placebo

• Registration Number: NCT01951235
• Lead Sponsor: Poxel SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-26
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-07
• Disposition First Submitted: 2015-07-02
• Disposition First Submitted QC: 2015-07-24
• Last Update Submitted: 2015-07-24
• Disposition First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imeglimin (Dose 1)	Imeglimin	-
Imeglimin (Dose 2)	Imeglimin	-
Imeglimin (Dose 3)	Imeglimin	-
Imeglimin (Dose 4)	Imeglimin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline and week 24

Secondary Outcome Measures

Name	Time	Method
Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG)	Baseline to week 24

Trial Locations

Locations (1)

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia