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Clinical Trial Details

Trial ID: L7127
Source ID: NCT01159353
Associated Drug: Insulin Glulisine
Title: Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glulisine|DRUG: Insulin aspart
Outcome Measures: Primary: Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h), At day 1 of each treatment period | Secondary: Area under the curve of plasma glucose concentration AUC(0-2h), At day 1 of each treatment period|Area under the curve of plasma glucose concentration AUC(0-4h), At day 1 of each treatment period|Area under the curve of plasma glucose concentration AUC(0-6h), At day 1 of each treatment period|Delta plasma glucose at 1h after standard meal, At day 1 of each treatment period|Maximum glucose concentration (GLU max), At day 1 of each treatment period|Maximum glucose excursion (delta GLU max), At day 1 of each treatment period|Time to delta GLU max, At day 1 of each treatment period|Time to fraction of total glucose AUC(10%, 20%), At day 1 of each treatment period|Area under the plasma insulin concentration curve AUC (0-1h), At day 1 of each treatment period|Area under the plasma insulin concentration curve AUC (0-2h), At day 1 of each treatment period|Area under the plasma insulin concentration curve AUC (0-4h), At day 1 of each treatment period|Area under the plasma insulin concentration curve AUC (0-6h), At day 1 of each treatment period|Maximum insulin concentration (Cmax), At day 1 of each treatment period|Time to fraction of total insulin AUC (10%, 20%), At day 1 of each treatment period|Time to Cmax, At day 1 of each treatment period|Hypoglycaemia and adverse events, from randomization to the end of study
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 37
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-09
Completion Date: 2008-04
Results First Posted:
Last Update Posted: 2010-07-16
Locations: Sanofi-Aventis Administrative Office, Paris, France
URL: https://clinicaltrials.gov/show/NCT01159353