NCT00231725

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

June 27, 2007

Status Verified

June 1, 2007

First QC Date

September 30, 2005

Last Update Submit

June 26, 2007

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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.

Interventions

insulin lispro injection [rDNA origin] Low MixDRUG

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes
  • Already on Lilly insulin or beginning insulin therapy
  • to 75 years old inclusive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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

Location

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

Location

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

Location

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

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

September 1, 2005

Study Completion

April 1, 2006

Last Updated

June 27, 2007

Record last verified: 2007-06

Locations

US(1)ES(2)GB(1)