| Trial ID: | L6664 |
| Source ID: | NCT03156361
|
| Associated Drug: |
Hdv Insulin Lispro 100 Unit/Ml
|
| Title: |
21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type1 Diabetes Mellitus
|
| Interventions: |
DRUG: HDV insulin lispro 100 UNIT/mL|DRUG: Insulin Lispro 100 Units/mL
|
| Outcome Measures: |
Primary: Glucose area under the curve, To evaluate glucose response (incremental AUC) to standardized test meal challenge following 21 days of CSII treatment with HDV insulin lispro versus insulin lispro diluted with sterile water, 21 days | Secondary: total units Insulin, To compare insulin doses (basal, bolus and total) during HDV insulin lispro treatment, 21 days
|
| Sponsor/Collaborators: |
Sponsor: Diasome Pharmaceuticals | Collaborators: Integrium
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-05-18
|
| Completion Date: |
2018-03-15
|
| Results First Posted: |
|
| Last Update Posted: |
2018-07-31
|
| Locations: |
Atlanta Diabetes Association, Atlanta, Georgia, 30318, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03156361
|
