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OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment. (Optimise)

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ClinicalTrials.gov Identifier: NCT00681850
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease
Diabetes

Study Type : Observational
Actual Enrollment : 4027 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.
Study Start Date : March 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Control group
2
Benchmarking group



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00681850


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Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Hermans, M. Prof. UCL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eugène Vissers, MD, Therapeutic Area Leader Cardivascular and Diabetes., AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00681850     History of Changes
Other Study ID Numbers: D3560L00071
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: June 2010

Keywords provided by AstraZeneca:
Diabetes
Benchmarking
quality of patient care
Diabetic Population

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