Effect of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborator: Société Francophone du Diabète
• Treatments: Insulin

Criteria

Inclusion Criteria:

• Clinical diagnosis of type2 diabetes

• Body Mass Index between 27 and 33 kg / cm ²

• HbA1c < 8.5%

• Non-pathological Electrocardiogram

• Heart rate between 50 and 80 beats per minute at rest.

• Complete Blood Count (CBC) with no significant anomaly in terms of the investigator..

• Serum electrolytes without clinically significant abnormalities in terms of the investigator.

• Liver function tests without clinically significant abnormalities in terms of the investigator

• Renal function tests without clinically significant abnormalities in terms of the investigator

• Good peripheral vein (forearm and back of the hand).

• Agreement to participate in the establishment of a serum bank.

• Ability to sign informed consent.

• Affiliation to a social security scheme

Exclusion Criteria:

• Secondary prevention of cardio-vascular disease

• Insulin therapy or Glucagon Like Peptid 1 (GLP-1) analogs therapy in the 6 months before inclusion.

• Risk factor, treatment or electrocardiogram as recommended by International Conference on Harmonization (ICH) E14 "Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs"

• Repeated a QTc interval> 450 ms measurement

• Risk factor for torsade de pointes: myocardial infarction, hypokalemia, family history of long QT syndrome

• Personal history of cancer.

• Positive HIV serology.

• Hepatitis B serology positive.

• Positive hepatitis C serology.

• Cognitive impairment or mental illness (at the discretion of the investigator).

• Chronic excessive alcohol consumption (consumption > 30g/day or 210g/week).

• Person under judicial protection, guardianship.

• Subject with a resting systolic blood pressure greater than 140 mm Hg and diastolic blood pressure greater than 90 mmHg

• Smoking more than 10 cigaret per day and can not be interrupted for 24 hours.