Type 2 Diabetes Mellitus MedDRA version: 12.1 Level: LLT Classification code 10012607 Term: Diabetes mellitus inadequate control
Conditions
Interventions
Product Name: imeglimin
Product Code: PXL008
Pharmaceutical Form: Tablet
INN or Proposed INN: imeglimin
Current Sponsor code: PXL008
Concentration unit: IU/mg international unit(s)/milligram
Concentra
Sponsors
Poxel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female type 2 diabetic subjects inadequately controlled by metformin monotherapy (1500 mg to 2000 mg per day, both inclusive) as defined by HbA1c = 7.5% - Monotherapy with metformin stable for at least 10 weeks before randomization - Age: = 18 to = 70 years - Body Mass Index (BMI): = 20 to = 40 kg/m² - HbA1c: = 7.5% and = 10% - No treatment with any other oral anti-diabetic, including insulin within 3 months before randomization - Creatinine clearance as estimated by the MDRD formula: = 80 mL/min/SSA (Standard Surface Unit = 1.73 m²) - Permitted concomitant medication stable for at least 14 days before randomization - Effective contraception for women of child bearing potential as defined by an accepted highly effective method of birth control with a low failure rate - Subject has given written informed consent before any study-related activities are carried out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any disease which in the investigator’s opinion would exclude the subject from the study - Diagnosis of type 1 diabetes - Acute condition which can impair renal function e.g. severe infectious disease or dehydration Uncontrolled high blood pressure (BP): diastolic = 100 mm Hg and systolic = 180 mm Hg - History of drug- induced Torsade de Pointe or presence of a familial long QT syndrome - Impairment of hepatic function (alkaline phosphatase [AP], aspartate aminotransferase [AST] or alanine aminotransferase [ALT] = 3 x the upper limit of normal) - Pregnancy or lactation - Mental handicap, legal incapacity, or any history of clinically important emotional and/or psychiatric illness - Presence of a contraindication to the study medication or to metformin - Known hypersensitivity to any of the constituents or excipients of the study drug or history with relevant drug (anaphylactic, anaphylactoid reactions) - Evidence of retinopathy of severity =35 in the Classification of Retinopathy Severity (as defined by the Early Treatment Diabetic Retinopathy Study and outlined in Appendix II). An examination by an ophthalmologist within 12 months before randomization is strongly recommended - Change in currently used medication and/or use of any new prescription or non-prescription medication within 14 days prior to randomization. The occasional use of paracetamol is not prohibited - Positive screen for hepatitis B surface antigen (HbsAg), antibody to the hepatitis A virus (Anti-HAV - Immunoglobulin M), antibody to the hepatitis C virus (Anti- HCV), or antibodies to human immunodeficiency (Anti- HIV) 1 and 2 virus - Any history of alcohol abuse or drug addiction - Smoking of more than 10 cigarettes, 3 cigars or 3 pipes per day - Participation in a clinical study within 30 days before randomization - Donation of blood within 30 days before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect on HbA1c of a 12-week treatment with imeglimin versus placebo add-on therapy in type 2 diabetic subjects not adequately controlled by metformin monotherapy.;Secondary Objective: - To assess the effect on other glycemic and on non glycemic parameters of a 12-week treatment with imeglimin versus placebo add-on therapy in type 2 diabetic subjects not adequately controlled by metformin monotherapy. - To assess the safety and tolerability of a 12-week treatment with imeglimin versus placebo add-on therapy in type 2 diabetic subjects not adequately controlled by metformin monotherapy. - To assess imeglimin pre-dose and optionally post-dose plasma concentrations in the plasma at each visit.;Primary end point(s): Change in HbA1c from baseline to week 12 | — |
Countries
Hungary, Latvia
Outcome results
None listed