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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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, 85101
Turkey
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, 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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014