Type 2 DiabetesDCA09NCT00979394
Evaluation of Diabetes Care at Austrian GPs
An observational study of Type 2 Diabetes, run by AstraZeneca.
Trial summary
This registery should show the medical care of patient with Type 2 Diabetes (T2D) at GP-offices. Furthermore data of co morbidities and risk factors should be evaluated. Objectives of this NIS (cross-sectional study) are: To evaluate which characteristics or co-morbidities are being existent for patient with T2D at GP… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 1,513 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: GPs
Who may be able to join
- Diabetes mellitus type II
Who cannot join
- Diabetes mellitus type I
- Gestation diabetes
- Induced diabetes
About this study
Official title: Diabetes Care Austria 2009
This registery should show the medical care of patient with Type 2 Diabetes (T2D) at GP-offices. Furthermore data of co morbidities and risk factors should be evaluated. Objectives of this NIS (cross-sectional study) are:
- To evaluate which characteristics or co-morbidities are being existent for patient with T2D at GP level,
- To evaluate representative profile of patient with T2D in Austria,
- To evaluate which medical therapies are used.
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Care at GPs in Austria, Characteristic of diabetes patients at GPs in Austria
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate characteristics or co morbidities being existent for patient with T2D at GP
Measured: Once per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 1,513 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Bernhard Ludvig, Study chair, General Hospital ViennaGuntram Schernthaner, Study chair, Krankenanstalt Rudolfsstiftung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979394
- Sponsor's protocol ID
- NIS-CAT-DUM-2009/1
- Acronym
- DCA09
- Status last verified
- Aug 2010
- First submitted
- 17 Sep 2009
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Care Austria 2009
- ClinicalTrials.gov ID
- NCT00979394
- Acronym / sponsor ID
- DCA09 / NIS-CAT-DUM-2009/1
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Care at GPs in Austria, Characteristic of diabetes patients at GPs in Austria
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,513 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Sep 2009 (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.
This registery should show the medical care of patient with Type 2 Diabetes (T2D) at GP-offices. Furthermore data of co morbidities and risk factors should be evaluated. Objectives of this NIS (cross-sectional study) are:
- To evaluate which characteristics or co-morbidities are being existent for patient with T2D at GP level,
- To evaluate representative profile of patient with T2D in Austria,
- To evaluate which medical therapies are used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- GPs
Key inclusion criteria (1 listed)
- Diabetes mellitus type II
Key exclusion criteria (3 listed)
- Diabetes mellitus type I
- Gestation diabetes
- Induced diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate characteristics or co morbidities being existent for patient with T2D at GP
Time frame: Once per patient
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
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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.
Bernhard Ludvig study chair
General Hospital Vienna
Guntram Schernthaner study chair
Krankenanstalt Rudolfsstiftung
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by AstraZeneca.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Evaluate characteristics or co morbidities being existent for patient with T2D at GP (time frame: Once per patient). 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 17 Aug 2010.