Clinical Trial Details
| Trial ID: | L2225 |
| Source ID: | NCT00231725 |
| Associated Drug: | Insulin Lispro Injection [Rdna Origin] Low Mix |
| Title: | Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: insulin lispro injection [rDNA origin] Low Mix |
| Outcome Measures: | Primary: To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months. | Secondary: To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia|To assess overall patient perception of the device's performance through a patient questionnaire. |
| Sponsor/Collaborators: | Sponsor: Eli Lilly and Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 370 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: |
| Start Date: | 2005-09 |
| Completion Date: | 2006-04 |
| Results First Posted: | |
| Last Update Posted: | 2007-06-27 |
| Locations: | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Memphis, Tennessee, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pamplona, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Requena, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Middlesbrough, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00231725 |
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