| Trial ID: | L6245 |
| Source ID: | NCT02324309
|
| Associated Drug: |
Biod-531
|
| Title: |
BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: BIOD-531|DRUG: Humalog Mix 75/25|DRUG: Humulin R U-500|DRUG: BIOD-531
|
| Outcome Measures: |
Primary: Post-breakfast glucose exposure (AUC), 0-330 minutes | Secondary: Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations), 0-330 and 660-1020 minutes|Insulin exposure (AUC), 0-1440 minutes|Maximal insulin concentration, 0-330 and 660-1020 minutes|Post-lunch and post-dinner glucose exposures (AUC), 330-660 and 660-1020 minutes|Injection site toleration (VAS and severity scales), 30 and 690 minutes
|
| Sponsor/Collaborators: |
Sponsor: Biodel
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2016-02-08
|
| Locations: |
Profil Institute for Clinical Research, Inc. (PICR), Chula Vista, California, 91911, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02324309
|
