Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin

Eli Lilly and Company370 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

370

Conditions

Type 2 Diabetes Mellitus

Interventions

insulin lispro injection [rDNA origin] Low MixDRUG

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Pamplona, Spain

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.