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ClinicalTrials.gov Identifier: NCT03549754
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes and established micro- and/or macrovascular disease

Condition or disease
Type 2 Diabetes

Detailed Description:
The registry intends to provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes and established micro- and/or macrovascular disease. Countries involved may vary depending on the interest shown by investigators and authorities all over the world

Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Real World Data on Patient Management and Quality of Care
Actual Study Start Date : February 17, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 1. Provide real world data on patient characteristics [ Time Frame: Average of 3 years through study completion ]
    Patient demography Patient height & weight, blood pressure Diabetes and general medical history Laboratory test results

  2. 2. Provide real world data on disease management [ Time Frame: Average of 3 years through study completion ]
    Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes treatments Concomitant medications

  3. 3. Provide real world data on healthcare utilization [ Time Frame: Average of 3 years through study completion ]
    Number of diabetes-related visits to a physician not at study site Number of urgent care visits for diabetes Number of diabetes-related hospital emergency department visits and reason(s) for visits Number of hospitalizations, lengths of stay, and reasons for hospitalizations

  4. 4. Provide real world data on quality of care indicators [ Time Frame: Average of 3 years through study completion ]
    Smoking cessation Eye and foot examinations Dietary counselling

  5. 5. Provide real world data on cardiovascular outcomes in patients with type 2 diabetes [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events

  6. 6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with type 2 diabetes
Criteria

Inclusion Criteria:

  1. Being 18 years or older
  2. Having type 2 diabetes
  3. Providing written informed consent to participate in the registry

Exclusion Criteria:

  1. Having type 1 diabetes
  2. Being currently pregnant or nursing (lactating)
  3. Having a life-threatening co-morbidity with life expectancy below 1 year
  4. Participating in an interventional trial requiring informed consent

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): NCT03549754


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 101 Study Locations
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03549754     History of Changes
Other Study ID Numbers: D1690R00044
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:
Registry
Type 2 Diabetes
T2DM
Adult population

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