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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 : Completed
First Posted : December 23, 2014
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date December 19, 2014
First Posted Date December 23, 2014
Last Update Posted Date September 24, 2019
Actual Study Start Date December 30, 2014
Actual Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02322762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 19, 2014)
  • Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure. [ Time Frame: Up to 3 years ]
  • Changes in anti-diabetic treatments [ Time Frame: Up to 3 years ]
  • Disease progression (incidence of microvascular and macrovascular complications). [ Time Frame: Up to 3 years ]
  • Incidence of hypoglycemic events. [ Time Frame: Up to 3 years ]
  • Quality of Life, using Patient Reported Outcomes questionnaires. [ Time Frame: Up to 3 years ]
  • Use of Healthcare resources. [ Time Frame: Up to 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
Official Title DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Type 2 Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2018)
14173
Original Estimated Enrollment
 (submitted: December 19, 2014)
13350
Actual Study Completion Date August 21, 2019
Actual Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries Algeria,   Argentina,   Austria,   Bahrain,   Brazil,   Canada,   China,   Colombia,   Costa Rica,   Czech Republic,   Czechia,   Denmark,   Egypt,   France,   Germany,   India,   Indonesia,   Italy,   Jordan,   Korea, Republic of,   Kuwait,   Lebanon,   Malaysia,   Mexico,   Netherlands,   Norway,   Oman,   Panama,   Poland,   Russian Federation,   Saudi Arabia,   South Africa,   Spain,   Sweden,   Taiwan,   Tunisia,   Turkey,   United Arab Emirates,   United Kingdom
 
Administrative Information
NCT Number NCT02322762
Other Study ID Numbers D1690R00002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
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
PRS Account AstraZeneca
Verification Date September 2019