| Trial ID: | L5425 |
| Source ID: | NCT01811849
|
| Associated Drug: |
Insulin Lispro
|
| Title: |
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Insulin LISPRO|DRUG: Insulin LISPRO|DRUG: Insulin LISPRO
|
| Outcome Measures: |
Primary: Time to 1/2 maximal insulin concentration, 480 minutes | Secondary: Time to maximal insulin concentration, 480 minutes|Time to 1/2 maximal insulin concentration after peak, 480 minutes|Visual analog scale, 30 minutes|AUC 0-30 and AUC 0-60, 60 minutes
|
| Sponsor/Collaborators: |
Sponsor: Biodel
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-08
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2013-03-15
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01811849
|
