A Retrospective Study of Cardiovascular Events Related to the Use of 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.

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Key information

Conditions

Diabetes Type II Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ROSE

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 12, 2010
Registry last updated: May 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed