Clinical study to asses whether the treatment with the drug imeglimin in combination with the drug sitagliptin in treatment of adult-onset sugar diabetes is safe and more effective than treatment with sitagliptin alone. The treatments will be assigned randomly and neither the patients nor their doctor will know what treatment is given, as those who will receive sitagliptin alone, for masking purposes, will also be given placebo - dummy tablets that look just like imeglimin.

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 13.1Level: PTClassification code 10012607Term: Diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-023915-33-SK
• Lead Sponsor: POXEL S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-23
• Last Update Posted: 1 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Inclusions criteria at Visit 1
• Subject has given written informed consent before any study-related activities are carried out
• Male or female type 2 diabetic subjects either
o Naïve of treatment with an HbA1c = 8.5% and = 10.5% or
o Inadequately controlled by metformin monotherapy at a dose = 1500 mg/day with an HbA1c = 7.5% and = 10%
o Inadequately controlled by an alpha glucosidase inhibitor with an HbA1c and = 8% and = 10%
o Inadequately controlled by a sulfonylurea or glinide with an HbA1c = 7.5% and = 10%
• Age: = 18 to = 75 years
• Body Mass Index (BMI): = 20 to = 40 kg/m²
• No treatment with TZD or insulin (except short use of insulin in the dedicated context of a concomitant disease or surgery intervention) within 12 weeks before randomization
• Creatinine clearance as estimated by the MDRD formula: = 60 ml/min
• Permitted concomitant medication stable for at least 14 days before randomization
• Effective contraception for women of child bearing potential

Inclusion criteria at Visit 6
• Subject has given written informed consent before any study-related activities are carried out
• Male or female type 2 diabetic subjects inadequately controlled by sitagliptin monotherapy (100 mg per day) as defined by HbA1c = 7.5%
• Monotherapy with sitagliptin stable for at least 12 weeks before randomization
• HbA1c: = 7.5% and = 10%
• Age: = 18 to = 75 years
• Body Mass Index (BMI): = 20 to = 40 kg/m²
• No treatment with TZD or insulin (except short use of insulin in the dedicated context of a concomitant disease or surgery intervention) within 12 weeks before randomization
• Creatinine clearance as estimated by the MDRD formula: = 60 ml/min
• Permitted concomitant medication stable for at least 14 days before randomization
• Effective contraception for women of child bearing potential
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Any disease which in the investigator’s opinion would exclude the subject from the study
• Uncontrolled high blood pressure (BP): diastolic = 95 mm Hg and systolic = 160 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 investigational medication, including sitagliptin
• Known hypersensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (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) assessed by an ophthalmologist within 12 months before randomization.
• 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 authorized
• 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 at screening
• Any history of alcohol abuse or drug addiction
• Participation in a clinical study within 60 days before randomization
• Donation of blood within 30 days before randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified