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Clinical Trial Details

Trial ID: L5537
Source ID: NCT02201199
Associated Drug: Insulin Glargine U200 Hoe901
Title: Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: insulin glargine U200 HOE901|DRUG: insulin glargine U500 HOE901|DRUG: insulin glargine U100 HOE901
Outcome Measures: Primary: Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing, 12 hours | Secondary: INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36), 36 hours|AUC up to the last measurable concentration, 36 hours|Time to reach 50% of INS-AUC 0-36, 36 hours|Time to reach INS-Cmax (INS-tmax), 36 hours|Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36), 36 hours|Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36), 36 hours|Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax), 36 hours|Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels), 4 days|Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters), 4 days
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-08
Completion Date: 2014-11
Results First Posted:
Last Update Posted: 2014-12-24
Locations: Investigational Site Number 276001, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT02201199