- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00231725
Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin
June 26, 2007 updated by: Eli Lilly and Company
Complaints Associated With Use of Pre-Filled Pen B When Used by Patients With Type 2 Diabetes on Twice-Daily Insulin Therapy
Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations.
Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily during the trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
370
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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.
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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.
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Middlesbrough, United Kingdom
- 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.
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Tennessee
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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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 Diabetes
- Already on Lilly insulin or beginning insulin therapy
- 25 to 75 years old inclusive
Exclusion Criteria:
- Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country
- More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia
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To assess overall patient perception of the device's performance through a patient questionnaire.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
September 30, 2005
First Submitted That Met QC Criteria
September 30, 2005
First Posted (Estimate)
October 4, 2005
Study Record Updates
Last Update Posted (Estimate)
June 27, 2007
Last Update Submitted That Met QC Criteria
June 26, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9673 (Other Identifier: CTEP)
- H9D-MC-ITAB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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