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An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin

NCT ID: NCT00549887

Last Updated: 2010-03-16

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

Total Enrollment

2459 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to estimate the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and short-acting human insulin therapy within the first year following the switch. The additional goals are: 1)to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient quality of life, 3) to assess the impact of switch from or to the rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate the total costs (direct and indirect) associated with switching, in either direction between rapid-acting analog and short-acting human insulin within the first year following the switch.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rapid acting to short acting

Patients on rapid-acting analog insulins who switch to short-acting human insulin

Analog or Human Insulin

Intervention Type DRUG

prescribed in accordance with usual clinical practice

Short acting to rapid acting

Patients on short-acting human insulins who switch to rapid-acting analog insulin

Analog or Human Insulin

Intervention Type DRUG

prescribed in accordance with usual clinical practice

Interventions

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Analog or Human Insulin

prescribed in accordance with usual clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* are at least 18 years of age
* according to the clinical judgement of the investigator have been diagnosed with type II diabetes
* have presented within the normal course of care
* at the baseline visit are being treated with any therapy including a rapid-acting analog insulin component or any therapy including a short-acting human insulin component and are switching from one form of therapy to the other
* are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
* have been fully informed and have given their written consent for the use of their data
* have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

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.

Purkersdorf, , Austria

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.

Beroun, , Czechia

Site Status

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Bad Homburg, , Germany

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.

Athens, , Greece

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.

Békéscsaba, , Hungary

Site Status

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Budapest, , Hungary

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.

Dombóvár, , Hungary

Site Status

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Dunaújváros, , Hungary

Site Status

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Eger, , Hungary

Site Status

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Esztergom, , Hungary

Site Status

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Gyula, , Hungary

Site Status

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Hódmezővásárhely, , Hungary

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.

Kaposvár, , Hungary

Site Status

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Karcag, , Hungary

Site Status

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Kecskemét, , Hungary

Site Status

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Kisbér, , Hungary

Site Status

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Makó, , Hungary

Site Status

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Mosonmagyaróvár, , Hungary

Site Status

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Nagykanizsa, , Hungary

Site Status

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Orosháza, , Hungary

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.

Pápa, , Hungary

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.

Pécs, , Hungary

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.

Szekszárd, , Hungary

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.

Oleśnica, , Poland

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.

Bucharest, , Romania

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.

Bratislava, , Slovakia

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.

Konya, , Turkey (Türkiye)

Site Status

Countries

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Austria Czechia Germany Greece Hungary Poland Romania Slovakia Turkey (Türkiye)

Other Identifiers

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F3Z-EW-B003

Identifier Type: OTHER

Identifier Source: secondary_id

11760

Identifier Type: -

Identifier Source: org_study_id

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