| Trial ID: | L6327 |
| Source ID: | NCT00553488
|
| Associated Drug: |
Regular Insulin (Humulin)
|
| Title: |
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Regular insulin (Humulin)|DRUG: Insulin lispro (Humalog)
|
| Outcome Measures: |
Primary: Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction., 90 mins | Secondary: Maximal BG (BGmax), Approximately 4 hours per injection|Total BG-AUC0-4 h, Approximately 4 hrs per injection|Minimal BG (BGmin, time to BGmin (tBGmin), Approximately 4 hrs per injection|Insulin pharmacokinetics, Approximately 4 hrs per injection|Number and seriousness of adverse events, Approximately 4 hrs per injections|Vital signs, examination of insulin application, Approximately 4 hrs per injection|Time to BGmax (tBGmax), Approximately 4 hours per injection
|
| Sponsor/Collaborators: |
Sponsor: Becton, Dickinson and Company
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-09
|
| Completion Date: |
2008-01
|
| Results First Posted: |
|
| Last Update Posted: |
2008-08-22
|
| Locations: |
Profil Institut fur Stoffwechselforschung GmbH, Neuss, D-41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00553488
|
