A Retrospective Study of Cardiovascular Events Related to the Use of Glucose Lowering Drug Treatment in Primary Care

Diabetes Type II Clinical Trial

— ROSE  

Official title:

A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Glucose Lowering Drug Treatment in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121315
• Other study ID #: NIS-CSE-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: May 10, 2012
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical 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 complications.

Recruitment information / eligibility

• 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type II

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

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