| Trial ID: | L4547 |
| Source ID: | NCT02910518
|
| Associated Drug: |
Insulin Glulisine (U300)
|
| Title: |
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type1 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin glulisine (U300)|DRUG: Insulin glulisine|DRUG: Insulin aspart|DRUG: NPH insulin|DRUG: Glucagon|DRUG: Glucose|DRUG: Heparin
|
| Outcome Measures: |
Primary: Assessment of PK parameter: maximum observed insulin concentration, 10 hours|Assessment of PK parameter: area under the concentration time curve, 10 hours | Secondary: Assessment of PK parameter: time to reach Cmax (INS-tmax), 10 hours|Assessment of PK parameter: terminal half-life (INS-t1/2z), 10 hours|Assessment of PD parameter: area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 10 hours (GIR-AUC0-10), 10 hours|Assessment of PD parameter: maximum smoothed body weight standardized GIR (GIRmax), 10 hours|Assessment of PD parameter: time to GIRmax (GIR-tmax), 10 hours|Duration of blood glucose control under clamp conditions - time, 10 hours|Number of patients with treatment emergent adverse events, 9 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-02-17
|
| Completion Date: |
2017-05-03
|
| Results First Posted: |
|
| Last Update Posted: |
2022-04-25
|
| Locations: |
Investigational Site Number 276001, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02910518
|
