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Trial record 36 of 7511 for:    Type 2 Diabetes

DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings (DISCOVER)

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.
ClinicalTrials.gov Identifier: NCT02322762
Recruitment Status : Active, not recruiting
First Posted : December 23, 2014
Last Update Posted : December 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
DISCOVER is a Non Interventional Study study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment.

Condition or disease
Type 2 Diabetes Mellitus

Detailed Description:
DISCOVER is a NIS study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment. This study is a multi-country, multicenter, observational, prospective, longitudinal cohort study. The patients will be recruitted from countries in Latin America, Europe and Asia pac. It is estimated that approximately 13350 patients will be enrolled in total with each patient followed up for 3 years.

Study Design

Study Type : Observational
Estimated Enrollment : 13350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
Actual Study Start Date : December 30, 2014
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
One single cohort.
One single cohort of patients with type 2 diabetes mellitus initiating their second line anti-diabetic therapy after first line anti-diabetic therapy.


Outcome Measures

Primary Outcome Measures :
  1. Anti-diabetic treatments prescribed by physicians in a real-world setting. [ Time Frame: Up to 3 Years ]
    The drugs (or their combinations) prescribed by physicians to patients initiating a 2nd line anti-diabetic treatment in a real-world setting will be described at inclusion and during 3 years follow-up.


Secondary Outcome Measures :
  1. Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure. [ Time Frame: Up to 3 years ]
  2. Changes in anti-diabetic treatments [ Time Frame: Up to 3 years ]
  3. Disease progression (incidence of microvascular and macrovascular complications). [ Time Frame: Up to 3 years ]
  4. Incidence of hypoglycemic events. [ Time Frame: Up to 3 years ]
  5. Quality of Life, using Patient Reported Outcomes questionnaires. [ Time Frame: Up to 3 years ]
  6. Use of Healthcare resources. [ Time Frame: Up to 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Patients with type 2 diabetes mellitus initiating their second line anti-diabetic therapy after first line anti-diabetic therapy. Participating investigators will belong to primary, secondary or tertiary care clinics or hospitals in proportions trying to resemble the reality of management of this type of patients in each country.
Criteria

Inclusion Criteria:

  1. Provision of subject informed consent
  2. Female or male aged 18 years and over
  3. Diagnosed with type 2 diabetes mellitus
  4. Initiating a second line anti-diabetic therapy, either as add-on, or switching from one monotherapy to another.

Exclusion Criteria:

  1. Diagnosis of type 1 diabetes mellitus
  2. Patient is pregnant
  3. Patients initiating a dual therapy after having previously received two different lines of monotherapy before (e.g.: Metformin → SU (Sulphonylureas) → SU+Add-on)
  4. Current treatment with chemotherapy, oral or iv steroids
  5. Patient is on dialysis or has had a renal transplant
  6. The patient is taking insulin as first line treatment
  7. The patient is taking dual therapy or a fixed dose combination treatment as first line treatment.
  8. The patient is taking herbal remedies / natural medicines as first line treatment
  9. Participation in an interventional trial
  10. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient for 3 years (e.g. lifethreatening co-morbidities, tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, dementia, alcohol or drug abuse).
  11. Not willing to sign the informed consent.
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): NCT02322762


  Show 371 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jesus Medina, PhD AstraZeneca
Principal Investigator: Linong Ji, MD Peking University People's Hospital, China
Principal Investigator: Bong Soo Cha, Dr. Severance Hospital, Yonsei University Health System
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02322762     History of Changes
Other Study ID Numbers: D1690R00002
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 1, 2017
Last Verified: November 2017

Keywords provided by AstraZeneca:
Type 2 diabetes mellitus
Anti-diabetic management patterns

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs