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Clinical Trial Details

Trial ID: L4044
Source ID: NCT02273258
Associated Drug: Sar342434
Title: A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: SAR342434|DRUG: Insulin Lispro|DRUG: Insulin Lispro
Outcome Measures: Primary: Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog, 12 hours|Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog, 12 hours|Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12), 12 hours | Secondary: The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X), 12 hours|Time to 20% of AUC (t20%-AUC), 12 hours|NS-tmax, INS-t1/2z, 12 hours|The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X), 12 hours|Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h), 12 hours|Maximum smoothed body weight standardized GIR (GIRmax), 12 hours|Time to GIRmax (GIR-tmax), 12 hours|Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels), 12 hours|Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia, 8 weeks
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-03
Completion Date: 2013-07
Results First Posted:
Last Update Posted: 2014-10-23
Locations: Sanofi Administrative Office, Frankfurt, Germany
URL: https://clinicaltrials.gov/show/NCT02273258