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NCT Number: NCT01951235

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imeglimin

Drug

Placebo

Drug

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline and week 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Poxel SA

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2013
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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