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

May 10, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

58326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Diabetes type II patients, according to medical records, prescriptions or lab results, followed for >6 months after diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
The endpoints will be extracted from the medical records on one occassion, covering a period of one decade.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Leif Lohm, MD, AstraZeneca Nordic, Södertälje
  • Principal Investigator: Gunnar Johansson, MD, Uppsala University, Sweden
  • Study Chair: Carl Johan Östgren, MD, Ödeshögs VC
  • Study Chair: Johan Sundström, MD PhD, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

May 11, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CSE-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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