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NCT Number: NCT00549887

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analog or Human Insulin

Drug

prescribed in accordance with usual clinical practice

Primary outcomes

  1. 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 outcomes

  1. Change in Euro Quality of Life (EQ-5D)

    Time frame: 1 year

  2. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame: 1 year

  3. Change in Diabetes Health Profile (DHP-18)

    Time frame: 1 year

  4. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING)

Acronym: SWING

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2007
Registry last updated
Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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