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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Analog or Human Insulin

• Registration Number: NCT00549887
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-26
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-15
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2459

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

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Exclusion Criteria

• no specific exclusion criteria exist for this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rapid acting to short acting	Analog or Human Insulin	Patients on rapid-acting analog insulins who switch to short-acting human insulin
Short acting to rapid acting	Analog or Human Insulin	Patients on short-acting human insulins who switch to rapid-acting analog insulin

Primary Outcome Measures

Name	Time	Method
The estimation of the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and a short-acting human insulin therapy within the first year following the switch.	1 year

Secondary Outcome Measures

Name	Time	Method
Change in Euro Quality of Life (EQ-5D)	1 year
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)	1 year
Change in Diabetes Health Profile (DHP-18)	1 year
The estimation of 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	1 year

Trial Locations

Locations (1)

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