type 2 diabetes
Conditions
Interventions
Product Name: (pyr1)-Apeline-13
Pharmaceutical Form: Powder and solution for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo:
Sponsors
CHU TOULOUSE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patient aged 40-65 years. Type 2 diabetes Diabetes treated with oral antidiabetic agents only BMI between 27 and 33 Kg / cm². HbA1c =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients experiencing secondary cardiovascular prevention. Diabetes treated by insulin or GLP-1 in the 6 months prior to inclusion Risk factor, treatment or ECG as recommended ICH E14 "Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs": - Repeated measurement of a QTc interval> 450 ms - Torsade de pointes risk factor: myocardial infarction, hypokalemia, family history of long QT syndrome Personal history of cancer. Positive HIV serology. Hepatitis B serology positive. Hepatitis C serology positive. Cognitive impairment or mental illness (at the discretion of the investigator) Excessive alcohol chronic use (consumption> 30g / day or 210g / week) Subject having a systolic blood pressure greater than the rest to 140 mm Hg and 90 mm Hg diastolic Smoking> 10 cig / day and can not be interrupted during 24 hours About participating in another research protocol or exclusion period from another protocol Nobody in safeguarding justice, guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the insulin sensitivity in volunteers with type 2 diabetes during a continuous infusion (pyr1) -Apeline-13 versus a placebo infusion.;Secondary Objective: Secondary objectives are to: 1) Get the tolerance and safety data for the administration of (pyr1) -Apeline-13 in humans, complementing data from published and ongoing studies, 2) Measure the plasma concentration of apelin depending on the administered dose, 3) Perform a serum bank for hormonal and metabolic posteriori trials (insulin, glucagon, apelin, other cytokines and hormones involved in energy metabolism).;Primary end point(s): The primary endpoint will be the measure of the difference between recent glucose infusion rate measured in the last 30 minutes of a hyperinsulinemic euglycemic clamp in the presence of a continuous infusion (pyr1) -Apeline-13 infusion rate glucose measured under the same conditions in the presence of a continuous infusion of placebo.;Timepoint(s) of evaluation of this end point: in the last 30 minutes of a hyperinsulinemic euglycemic clamp | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: - Calculation of the M factor (glucose metabolism) according ref De Fronzo (12, 37) - Variations of the measurement of the systolic blood pressure - Variations of the measurement of the diastolic blood pressure - Changes in heart rate measurement - Route of ECG Changes - Clinical signs of intolerance / allergy / toxicity - Determination of plasma insulin - Determination of glucagon - Determination of apelin - Determination of leptin - Determination of adiponectin;Timepoint(s) of evaluation of this end point: during each clamp | — |
Countries
France
Contacts
Public ContactCLINICAL RESEARCH ASSOCIATE
CHU TOULOUSE
Outcome results
None listed