Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DRUGinsulin lispro injection [rDNA origin] Low Mix
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain, United Kingdom, United States
Outcome results
None listed