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

NCT ID: NCT00231725

Last Updated: 2007-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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insulin lispro injection [rDNA origin] Low Mix

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

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

Site Status

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

Site Status

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

Site Status

Countries

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France Netherlands Puerto Rico United States Spain United Kingdom

Other Identifiers

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H9D-MC-ITAB

Identifier Type: -

Identifier Source: secondary_id

9673

Identifier Type: -

Identifier Source: org_study_id