Diabetes Type II Clinical Trial
— ROSEOfficial title:
A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Glucose Lowering Drug Treatment in Primary Care
Verified date | May 2012 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 58326 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with type II diabetes, according to medical records, diagnosis, prescription or lab assessments Exclusion Criteria: - Patients followed by physician for less than 6 months after diagnosis of Diabetes type II |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Sweden | Research Site | Uppsala |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite end-point consisting of Cardiovascular Disease, elective coronary revascularisation and mortality | The endpoints will be extracted from the medical records on one occassion, covering a period of one decade. | No | |
Secondary | Retinopathy, renal failure, hypoglycaemic episodes, other diabetic complications | The endpoints will be extracted from the medical records on one occasion, covering a period of one decade. | No | |
Secondary | Time from: Metformin (MET) to Insulin (INS) versus Metformin (MET) -> Metformin (MET)+Sulfonylurea (SU) ->Insulin (INS) | The endpoints will be extracted from the medical records on one occasion, covering a period of one decade. | No | |
Secondary | Number of consultations in primary care. Number of hospitalisations | The endpoints will be extracted from the medical records on one occasion, covering a period of one decade. | No |
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