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

July 24, 2015 updated by: Poxel SA

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Imeglimin (Dose 1)
Drug: Imeglimin
Experimental: Imeglimin (Dose 2)
Drug: Imeglimin
Experimental: Imeglimin (Dose 3)
Drug: Imeglimin
Experimental: Imeglimin (Dose 4)
Drug: Imeglimin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: Baseline and week 24
Baseline and week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poxel SA

Investigators

  • Principal Investigator: Valdis Pirags, MD, P. Stradins Clinical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 26, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

July 24, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PXL008-008
  • 2012-004045-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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