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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01121315

Acronym

ROSE

Enrollment

58326

Registered

2010-05-12

Start date

2010-05-31

Completion date

2011-08-31

Last updated

2012-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type II

Keywords

Epidemiological, Diabetes, Glucose Lowering Drug Treatment in Primary care, CVD

Brief 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.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.

Secondary

Measure	Time frame
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.
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.
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.

Countries

Sweden

Outcome results