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Clinical Trial Details

Trial ID: L1804
Source ID: NCT02724566
Associated Drug: Apelin
Title: Effect of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers
Acronym: APELINS-2
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: apelin|DRUG: placebo
Outcome Measures: Primary: Delta between Glucose Infusion Rate, Difference between glucose infusion rate measured during investigational product infusion (mean of values measured at 210, 215, 220, 225, 230, 235 and 240 minutes) and basal glucose infusion rate (mean of values measured at 90, 95, 100, 105, 110, 115 and 120 minutes)., 240 minutes | Secondary: Measure of M-value (a glucose physiological parameter), Difference between value of product time (mean of values measured at 210, 215, 220, 225, 230, 235 and 240 minutes) and value of basal (mean of values measured at 90, 95, 100, 105, 110, 115 and 120 minutes)., 240 minutes|systolic blood pressure and diastolic blood pressure, 240 minutes|heart rate, 240 minutes|Measure of QTc interval with electrocardiogram examination, 240 minutes|Clinic sign of apelin intolerance, 240 minutes|Dosage of plasma proteins, A kinetic is realized with samples at 0, 15, 30, 45, 60, 75, 90, 100, 110, 120, 135, 150, 165, 180, 195, 200, 220, 230 and 240 minutes, 240 minutes|Clinic sign of apelin allergy, Modification in physiological parameters, 240 minutes|Clinic sign of apelin toxicity, Modification in physiological parameters, 240 minutes
Sponsor/Collaborators: Sponsor: University Hospital, Toulouse | Collaborators: Société Francophone du Diabète
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 9
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2016-05
Completion Date: 2017-04
Results First Posted:
Last Update Posted: 2017-08-22
Locations: University Hospitals of Toulouse (Rangueil), Toulouse, Midi-Pyrénées, 31059, France
URL: https://clinicaltrials.gov/show/NCT02724566