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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951235
• Other study ID #: PXL008-008
• Secondary ID: 2012-004045-33
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2013
• Last updated: July 24, 2015
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Imeglimin

• Placebo

Locations

Country	Name	City	State
Latvia	Pauls Stradins Clinical University Hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Poxel SA

Country where clinical trial is conducted

Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		Baseline and week 24	No
Secondary	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	Yes