|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00549887 |
|
Date of registration:
|
23/10/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin
SWING |
|
Scientific title:
|
Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING) |
|
Date of first enrolment:
|
September 2007 |
|
Target sample size:
|
2459 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00549887 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Austria
|
Czech Republic
|
Germany
|
Greece
|
Hungary
|
Poland
|
Romania
|
Slovakia
|
|
Turkey
| | | | | | | |
|
Contacts
|
|
Name:
|
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) |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Eli Lilly and Company |
| | |
|
Key inclusion & exclusion criteria
|
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
Exclusion Criteria:
- no specific exclusion criteria exist for this study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes Mellitus, Type 2
|
|
Intervention(s)
|
|
Drug: Analog or Human Insulin
|
|
Primary Outcome(s)
|
|
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.
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
Change in Diabetes Health Profile (DHP-18)
[Time Frame: 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
[Time Frame: 1 year]
|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
[Time Frame: 1 year]
|
|
Change in Euro Quality of Life (EQ-5D)
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
F3Z-EW-B003
|
|
11760
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|