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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121315
First Posted: May 12, 2010
Last Update Posted: May 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition
Diabetes Type II

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Glucose Lowering Drug Treatment in Primary Care

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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. ]

Enrollment: 58326
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Diabetes type II patients, according to medical records, prescriptions or lab results, followed for >6 months after diagnosis.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121315


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01121315     History of Changes
Other Study ID Numbers: NIS-CSE-DUM-2010/1
First Submitted: May 10, 2010
First Posted: May 12, 2010
Last Update Posted: May 11, 2012
Last Verified: May 2012

Keywords provided by AstraZeneca:
Epidemiological
Diabetes
Glucose Lowering Drug Treatment in Primary care
CVD

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases