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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

Latvia

Study Type

Interventional

Intervention

Imeglimin

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pauls Stradins Clinical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Imeglimin (Dose 1)

Imeglimin (Dose 2)

Imeglimin (Dose 3)

Imeglimin (Dose 4)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01951235

First Posted

September 19, 2013

Last Updated

July 24, 2015

Sponsor

Poxel SA

1. Study Identification

Unique Protocol Identification Number

NCT01951235

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poxel SA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

315 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Imeglimin (Dose 1)

Arm Type

Experimental

Arm Title

Imeglimin (Dose 2)

Arm Type

Experimental

Arm Title

Imeglimin (Dose 3)

Arm Type

Experimental

Arm Title

Imeglimin (Dose 4)

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Imeglimin

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in HbA1c

Time Frame

Baseline and week 24

Secondary Outcome Measure Information:

Title

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)

Time Frame

Baseline to week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valdis Pirags, MD

Organizational Affiliation

P. Stradins Clinical University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pauls Stradins Clinical University Hospital

City

Riga

Country

Latvia

12. IPD Sharing Statement

Learn more about this trial

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

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