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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01121315
First received: May 10, 2010
Last updated: May 10, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: May 10, 2010
Last Updated: May 10, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on October 29, 2014