Clinical Trial Details
| Trial ID: | L3324 |
| Source ID: | NCT03903016 |
| Associated Drug: | Insulin Lispro Sar342434 |
| Title: | A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 1 Diabetes |
| Interventions: | DRUG: Insulin Lispro SAR342434|DRUG: Insulin Lispro SAR342434 |
| Outcome Measures: | Primary: Assessment of pharmacokinetc (PK) parameter:INS-Cmax, Maximum Insulin (INS) concentration, 10 hours|Assessment of PK parameter :INS-AUClast -, Area under INS concentration time curve from 0 to last measurable concentration -, 10 hours | Secondary: Assessment of PK parameter:INS-AUC, Area under INS concentration time curve from 0 to infinity, 10 hours|Assessment of PK parameter:INS-tmax, Time to reach INS-Cmax, 10 hours|Assessment of PK parameter:INS-t1/2z, INS terminal half life, 10 hours|Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8, Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours, 8 hours|Assessment of PD parameter:GIR-max, Maximum smoothed GIR, 8 hours|Assessment of PD parameter:GIR-tmax, Time to reach GIR-max, 8 hours|Duration of blood glucose control, Duration of blood glucose control at or below 105 mg/dL, 8 hours|Adverse Events, Number of participants with adverse events, Up to Day 62 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 90 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2019-03-26 |
| Completion Date: | 2019-08-19 |
| Results First Posted: | |
| Last Update Posted: | 2022-04-25 |
| Locations: | Investigational Site Number 2760001, Neuss, 41460, Germany |
| URL: | https://clinicaltrials.gov/show/NCT03903016 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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