| Trial ID: | L4010 |
| Source ID: | NCT02148250
|
| Associated Drug: |
U-500 Insulin, 100 Syringe Units
|
| Title: |
PK/PD Study of U-500 Regular Insulin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02148250/results
|
| Conditions: |
Type 2 Diabetes|Insulin Resistance|High Insulin Requirements
|
| Interventions: |
DRUG: U-500 insulin, 100 syringe units|DRUG: U-500 insulin, 200 syringe units
|
| Outcome Measures: |
Primary: Duration (in Hours) of 20 % Dextrose Infusion Requirement, 24 hours post insulin injection | Secondary: Peak Infusion Rate Achieved After U-500, 4 hours after insulin injection|Total Glucose Given After U-500 Dose, 4 hours|Time Following Injection the Glucose Infusion Was Started to Maintain EU, 24 hours|Total Glucose Required to Maintain Euglycaemia, 24 hours
|
| Sponsor/Collaborators: |
Sponsor: University of Minnesota | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
17
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-07
|
| Completion Date: |
2017-12
|
| Results First Posted: |
2020-02-26
|
| Last Update Posted: |
2020-02-26
|
| Locations: |
University of Minnesota, Minneapolis, Minnesota, 55455, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02148250
|
