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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951235
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Imeglimin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline and week 24 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951235


Locations
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Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Sponsors and Collaborators
Poxel SA
Investigators
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Principal Investigator: Valdis Pirags, MD P. Stradins Clinical University Hospital

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Responsible Party: Poxel SA
ClinicalTrials.gov Identifier: NCT01951235    
Other Study ID Numbers: PXL008-008
2012-004045-33 ( EudraCT Number )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases