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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00549887
First received: October 23, 2007
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Analog or Human Insulin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Euro Quality of Life (EQ-5D) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in Diabetes Health Profile (DHP-18) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2459
Study Start Date: September 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rapid acting to short acting
Patients on rapid-acting analog insulins who switch to short-acting human insulin
Drug: Analog or Human Insulin
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
Drug: Analog or Human Insulin
prescribed in accordance with usual clinical practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Type II Diabetes treated with a regimen which includes any rapid-acting analog insulin or any short-acting human insulin

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549887

Locations
Austria
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, 3002
Czech Republic
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Beroun, Czech Republic, 26601
Germany
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Bad Homburg, Germany, D-61350
Greece
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Athens, Greece, 11527
Hungary
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Bekescsaba, Hungary, 5600
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Budapest, Hungary, H-1139
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Dombovar, Hungary, 7200
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Dunaujvaros, Hungary, 2400
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Eger, Hungary, 3300
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Esztergom, Hungary, 2500
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Gyula, Hungary, 5700
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Hodmezovasarhely, Hungary, H-6800
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Kaposvar, Hungary, 7400
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Karcag, Hungary, 5301
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Kecskemet, Hungary, 6000
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Kisber, Hungary
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Mako, Hungary, 6900
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Mosonmagyarovar, Hungary, 9200
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Nagykanizsa, Hungary, 8800
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Oroshaza, Hungary, 5901
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Papa, Hungary, 8500
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Pecs, Hungary, 7623
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Szekszard, Hungary, 7100
Poland
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Olesnica, Poland
Romania
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Bucharest, Romania, 020045
Slovakia
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Bratislava, Slovakia, 85101
Turkey
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Konya, Turkey, 42075
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00549887     History of Changes
Other Study ID Numbers: 11760, F3Z-EW-B003
Study First Received: October 23, 2007
Last Updated: March 15, 2010
Health Authority: Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Poland: Ministry of Health
Bulgaria: Ministry of Health
Slovakia: State Institute for Drug Control
Slovenia: Ministry of Health
Croatia: Ministry of Health and Social Care
Turkey: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014