Diabetes Mellitus, Type 2SWINGNCT00549887
An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin
An observational study of Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 27 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Analog or Human Insulin
- How many people
- 2,459 participants
- Where
- 27 sitesin 9 countries
- Study dates
- Sep 2007to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type II Diabetes treated with a regimen which includes any rapid-acting analog insulin or any short-acting human insulin
Who may be able to join
- 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
Who cannot join
- no specific exclusion criteria exist for this study
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
Hungary19 sites
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.
Békéscsaba, 5600
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Budapest, H-1139
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Dombóvár, 7200
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Dunaújváros, 2400
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Eger, 3300
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Esztergom, 2500
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Gyula, 5700
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Hódmezővásárhely, H-6800
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Kaposvár, 7400
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Karcag, 5301
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Kecskemét, 6000
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Kisbér
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Makó, 6900
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Mosonmagyaróvár, 9200
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Nagykanizsa, 8800
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Orosháza, 5901
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Pápa, 8500
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Pécs, 7623
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Szekszárd, 7100
Austria1 site
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Purkersdorf, 3002
Czechia1 site
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Beroun, 26601
Germany1 site
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Bad Homburg, D-61350
Greece1 site
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Athens, 11527
Poland1 site
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Oleśnica
Romania1 site
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Bucharest, 020045
Slovakia1 site
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Bratislava, 85101
Turkey (Türkiye)1 site
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, 42075
About this study
Official title: Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING)
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Analog or Human Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analog or Human InsulinDrug
prescribed in accordance with usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Rapid acting to short acting | Patients on rapid-acting analog insulins who switch to short-acting human insulin Receives: Drug: Analog or Human Insulin | |
| Short acting to rapid acting | Patients on short-acting human insulins who switch to rapid-acting analog insulin Receives: Drug: Analog or Human Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Change in Euro Quality of Life (EQ-5D)
Measured: 1 year
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Measured: 1 year
Change in Diabetes Health Profile (DHP-18)
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549887
- Sponsor's protocol ID
- 11760
- Other IDs
- F3Z-EW-B003
- Acronym
- SWING
- Status last verified
- Mar 2010
- First submitted
- 23 Oct 2007
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING)
- ClinicalTrials.gov ID
- NCT00549887
- Acronym / sponsor ID
- SWING / 11760
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,459 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid acting to short acting | – | Drug: Analog or Human InsulinPatients on rapid-acting analog insulins who switch to short-acting human insulin |
| Short acting to rapid acting | – | Drug: Analog or Human InsulinPatients on short-acting human insulins who switch to rapid-acting analog insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type II Diabetes treated with a regimen which includes any rapid-acting analog insulin or any short-acting human insulin
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- no specific exclusion criteria exist for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analog or Human Insulinprescribed in accordance with usual clinical practice | Drug | Rapid acting to short acting, Short acting to rapid acting |
Primary outcome
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
4 secondary outcomes
Change in Euro Quality of Life (EQ-5D)
Time frame: 1 year
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 27 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Hungary, Austria, Czechia, Germany, Greece and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2010.