| Trial ID: | L3221 |
| Source ID: | NCT01235039
|
| Associated Drug: |
Viaject®25
|
| Title: |
A Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: VIAject®25|DRUG: VIAject®7|DRUG: Insulin Lispro
|
| Outcome Measures: |
Primary: Serum insulin concentration, Area under the serum insulin concentration curve for the time interval 0-480 min (AUC-INS 0-480) and maximum serum insulin concentration (C-INS max) (VIAject®7and VIAject®25 only), 0-480 minutes | Secondary: Serum insulin concentration, * AUC-INS: area under the serum insulin concentration curve for the time period 0-240 minutes * AUC-INS: area under the serum insulin concentration curve for the time period 0 (VIAject® dosing) to the time when the insulin value returns to baseline, 0-240 minutes|Glucose infusion rate, •AUCGIR: area under the glucose infusion rate curve for the following time periods: 0-240, 0-480 minutes, Between 0-240 minutes and 0-480 minutes
|
| Sponsor/Collaborators: |
Sponsor: Biodel
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
43
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-07
|
| Completion Date: |
2009-09
|
| Results First Posted: |
|
| Last Update Posted: |
2015-07-29
|
| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01235039
|
