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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01951235

Enrollment

315

Registered

2013-09-26

Start date

2013-01-31

Completion date

2014-07-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DRUGImeglimin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c	Baseline and week 24

Secondary

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)	Baseline to week 24

Countries

Latvia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026