OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment. - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00681850

Purpose

Demonstrate that the use of benchmarking improves quality of patient care, in particular the control of diabetes, lipids and blood pressure, by determining the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of follow-up.

Condition
Diabetes

MedlinePlus related topics: Cholesterol Diabetes

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

HbA1c, LDL-cholesterol, Systolic Blood Pressure [ Time Frame: Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glycaemia, Triglycerides, Total and HDL-Cholesterol, Diastolic Blood Pressure, Waist circumference, Smoking habits, Microalbuminuria, Body Mass Index, Physical activity (Rating scale and step counter), Degree of ophthalmic control and dietary advice [ Time Frame: Visit 1Visit 2 (after approximately 4 months after visit 1)Visit 3 (after approximately 8 months after visit 1)Visit 4 (after approximately 12 months after visit 1) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5000
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Control group
2 Benchmarking group

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

General Practioners

Criteria

Inclusion Criteria:

Provision of informed Consent
Patients suffering from diabetes type II, insulin dependent or not insulin dependent.

Exclusion Criteria:

Type I diabetes
Pregnancy diabetes
Hospitalisation, as this is a primary care study
Patients who are member of the Belgian Diabetes Convention

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681850

Contacts

Contact: AstraZeneca Belgium Clinical Study Information

32-2370-4394

annelies.vankeirsbilck@AstraZeneca.com

Show 292 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Hermans, M. Prof.

UCL

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Eugène Vissers, MD, Therapeutic Area Leader Cardivascular and Diabetes. )
Study ID Numbers:	D3560L00071
Study First Received:	May 19, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00681850
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:

Diabetes
Benchmarking
quality of patient care
Diabetic Population

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 13, 2009