Phase II study on type 2 diabetic subjects
Conditions
Interventions
Product Name: EMD 387008
Product Code: EMD 387008
Pharmaceutical Form: Capsule*
CAS Number: 775351-61-6
Current Sponsor code: EMD 387008
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Merck Santé s.a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female type 2 diabetic subjects who are not receiving antidiabetic treatment or who are being treated with antidiabetic monotherapy including metformin, sulfonylurea, glinide or acarbose· - Age between 18 and 70 years· - Body mass index (BMI) >=20 and =7.8 mmol/L and =140 mg/dL and =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· - Acute or chronic diseases which can cause severe tissue hypoxia, e.g. cardiac and respiratory insufficiency or acute myocardial infarction· - Acute conditions which can impair renal function, e.g. dehydration or severe infections· - Uncontrolled high blood pressure [BP] (diastolic BP >100 mmHg or systolic BP >180 mmHg)· - History of drug-induced Torsade de Pointes, or presence of a familial long QT syndrome· - Impairment of hepatic function (alkaline phosphatase or aspartate aminotransferase [AST], or alanine aminotransferase [ALT] >3 x the upper limit of normal)· - Evidence of retinopathy of severity >=35, in the Classification of Retinopathy Severity (Early Treatment Diabetic Retinopathy Study (assessed by an ophthalmologist in the 6 months preceding inclusion)· - Pregnancy or lactation· - History of any clinically important neurological disorders and/or epilepsy· - Mental handicap, legal incapacity, or any history of clinically important emotional and/or psychiatric illness· - Presence of a contraindication to the study medication, including metformin· - Known hypersensitivity to any of the constituents or excipients of the study drug and metformin tablets, or history of relevant drug and/or food allergies (e.g. anaphylactic, anaphylactoid reactions)· - 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 [IgM]), antibody to hepatitis C virus (anti-HCV) or antibodies to human immunodeficiency virus (anti-HIV) 1 and 2 at screening· - Any history of alcohol abuse or drug addiction· - Smoking of more than 10 cigarettes or 3 cigars or 3 pipes per day · - Participation in a clinical study within 60 days before randomization · - Donation of blood within 90 days before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the activity of EMD 387008 versus placebo on glycemic parameters in type 2 diabetic subjects after 8 weeks of treatment ;Primary end point(s): Meal test area under the curve (AUC) glucose with the following time points: - before meal test: -0h30, 0h· - after meal test: 0h10, 0h20, 0h30, 0h45, 1h, 1h30, 2h, 2h30, 3h, 4h, 5h, 6h;Secondary Objective: - Assessment of the activity of EMD 387008 versus placebo on non-glycemic parameters in type 2 diabetic subjects after 8 weeks of treatment· - Comparison of the effect of EMD 387008 versus metformin on glycemic and non-glycemic parameters in type 2 diabetic subjects after 8 weeks of treatment· - Assessment of the tolerability and safety of EMD 387008 versus placebo and metformin in type 2 diabetic subjects after 8 weeks of treatment· - Evaluation of pre-dose plasma concentrations of EMD 387008 and metformin during the course of the treatment and pre- and post-dose concentrations after 8 weeks of treatment in type 2 diabetic subjects and correlation with possible efficacy and/or safety· - Analysis of polymorphism in OCT-1 and OCT-2 transporters and correlation with both PK parameters and with efficacy and/or safety parameters | — |
Countries
Latvia
Outcome results
None listed