Diabetes Type IIROSENCT01121315
A Retrospective Study of Cardiovascular Events Related to the Use of Glucose Lowering Drug Treatment in Primary Care
An observational study of Diabetes Type II, run by AstraZeneca at 1 site in Sweden.
Trial summary
To describe the type II diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. To test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Type II
- How many people
- 58,326 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Aug 2011
- 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: Eligible subjects are all type II diabetes patients, found in medical records at the participating centres. Patient data from the period 1 January 1999 - 31 December 2009 will be included in the observation. To ensure a representative selection of primary care centers, selection of study sites will be based on the following criteria to ensure a representative sample of the Swedish population: a mix of rural and urban areas, public and private care providers, small, mid sized and large primary care centers.
Who may be able to join
- Patients with type II diabetes, according to medical records, diagnosis, prescription or lab assessments
Who cannot join
- Patients followed by physician for less than 6 months after diagnosis of Diabetes type II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Glucose Lowering Drug Treatment in Primary Care
To describe the type II diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. To test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic complications.
- Conditions
- Diabetes Type II
- Keywords
- Epidemiological, Diabetes, Glucose Lowering Drug Treatment in Primary care, CVD
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
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 |
|---|---|---|
| 1 | Diabetes type II patients, according to medical records, prescriptions or lab results, followed for >6 months after diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end-point consisting of Cardiovascular Disease, elective coronary revascularisation and mortality
Measured: The endpoints will be extracted from the medical records on one occassion, covering a period of one decade.
Secondary outcomes (3)
Retinopathy, renal failure, hypoglycaemic episodes, other diabetic complications
Measured: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
Time from: Metformin (MET) to Insulin (INS) versus Metformin (MET) -> Metformin (MET)+Sulfonylurea (SU) ->Insulin (INS)
Measured: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
Number of consultations in primary care. Number of hospitalisations
Measured: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type IIStudies 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
- Time perspective
- Retrospective
- Enrolment
- 58,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leif Lohm, MD, Study director, AstraZeneca Nordic, SödertäljeGunnar Johansson, MD, Principal investigator, Uppsala University, SwedenCarl Johan Östgren, MD, Study chair, Ödeshögs VCJohan Sundström, MD PhD, Study chair, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121315
- Sponsor's protocol ID
- NIS-CSE-DUM-2010/1
- Acronym
- ROSE
- Status last verified
- May 2012
- First submitted
- 10 May 2010
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Grundvold I, Bodegard J, Nilsson PM, Svennblad B, Johansson G, Ostgren CJ, Sundstrom J. Body weight and risk of atrial fibrillation in 7,169 patients with newly diagnosed type 2 diabetes; an observational study. Cardiovasc Diabetol. 2015 Jan 15;14:5. doi: 10.1186/s12933-014-0170-3.
PubMed 25589001Sundstrom J, Sheikhi R, Ostgren CJ, Svennblad B, Bodegard J, Nilsson PM, Johansson G. Blood pressure levels and risk of cardiovascular events and mortality in type-2 diabetes: cohort study of 34 009 primary care patients. J Hypertens. 2013 Aug;31(8):1603-10. doi: 10.1097/HJH.0b013e32836123aa.
PubMed 23625112Ostgren CJ, Sundstrom J, Svennblad B, Lohm L, Nilsson PM, Johansson G. Associations of HbA1c and educational level with risk of cardiovascular events in 32,871 drug-treated patients with Type 2 diabetes: a cohort study in primary care. Diabet Med. 2013 May;30(5):e170-7. doi: 10.1111/dme.12145. Epub 2013 Mar 13.
PubMed 23350893
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Glucose Lowering Drug Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT01121315
- Acronym / sponsor ID
- ROSE / NIS-CSE-DUM-2010/1
- Conditions
- Diabetes Type II
- Keywords
- Epidemiological, Diabetes, Glucose Lowering Drug Treatment in Primary care, CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58,326 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 May 2010 (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.
To describe the type II diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. To test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic complications.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Diabetes type II patients, according to medical records, prescriptions or lab results, followed for >6 months after diagnosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible subjects are all type II diabetes patients, found in medical records at the participating centres. Patient data from the period 1 January 1999 - 31 December 2009 will be included in the observation. To ensure a representative selection of primary care centers, selection of study sites will be based on the following criteria to ensure a representative sample of the Swedish population: a mix of rural and urban areas, public and private care providers, small, mid sized and large primary care centers.
Key inclusion criteria (1 listed)
- Patients with type II diabetes, according to medical records, diagnosis, prescription or lab assessments
Key exclusion criteria (1 listed)
- Patients followed by physician for less than 6 months after diagnosis of Diabetes type II
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
Composite end-point consisting of Cardiovascular Disease, elective coronary revascularisation and mortality
Time frame: The endpoints will be extracted from the medical records on one occassion, covering a period of one decade.
3 secondary outcomes
Retinopathy, renal failure, hypoglycaemic episodes, other diabetic complications
Time frame: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
Time from: Metformin (MET) to Insulin (INS) versus Metformin (MET) -> Metformin (MET)+Sulfonylurea (SU) ->Insulin (INS)
Time frame: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
Number of consultations in primary care. Number of hospitalisations
Time frame: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
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 11 May 2012.
- Derived from this study: PubMed 25589001Grundvold I, Bodegard J, Nilsson PM, Svennblad B, Johansson G, Ostgren CJ, Sundstrom J. Body weight and risk of atrial fibrillation in 7,169 patients with newly diagnosed type 2 diabetes; an observational study. Cardiovasc Diabetol. 2015 Jan 15;14:5. doi: 10.1186/s12933-014-0170-3.
- Derived from this study: PubMed 23625112Sundstrom J, Sheikhi R, Ostgren CJ, Svennblad B, Bodegard J, Nilsson PM, Johansson G. Blood pressure levels and risk of cardiovascular events and mortality in type-2 diabetes: cohort study of 34 009 primary care patients. J Hypertens. 2013 Aug;31(8):1603-10. doi: 10.1097/HJH.0b013e32836123aa.
- Derived from this study: PubMed 23350893Ostgren CJ, Sundstrom J, Svennblad B, Lohm L, Nilsson PM, Johansson G. Associations of HbA1c and educational level with risk of cardiovascular events in 32,871 drug-treated patients with Type 2 diabetes: a cohort study in primary care. Diabet Med. 2013 May;30(5):e170-7. doi: 10.1111/dme.12145. Epub 2013 Mar 13.
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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.
Leif Lohm, MD study director
AstraZeneca Nordic, Södertälje
Gunnar Johansson, MD principal investigator
Uppsala University, Sweden
Carl Johan Östgren, MD study chair
Ödeshögs VC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type II, run by AstraZeneca at 1 site in Sweden.
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 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 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Composite end-point consisting of Cardiovascular Disease, elective coronary revascularisation and mortality (time frame: The endpoints will be extracted from the medical records on one occassion, covering a period of one decade.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121315, which also lists 3 linked publications.
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 11 May 2012.