A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
- Registration Number
- NCT01951235
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imeglimin (Dose 1) Imeglimin - Imeglimin (Dose 2) Imeglimin - Imeglimin (Dose 3) Imeglimin - Imeglimin (Dose 4) Imeglimin - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in HbA1c Baseline and week 24
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Imeglimin in improving insulin sensitivity in type 2 diabetes?
How does Imeglimin compare to SGLT2 inhibitors in glycemic control for treatment-naive type 2 diabetes patients?
Which biomarkers correlate with response to Imeglimin in patients with type 2 diabetes mellitus?
What adverse events are associated with Imeglimin and how are they managed in clinical practice?
Are there combination therapies involving Imeglimin and GLP-1 receptor agonists for type 2 diabetes treatment?
Trial Locations
- Locations (1)
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Pauls Stradins Clinical University Hospital🇱🇻Riga, Latvia