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DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan (J-DISCOVER)

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ClinicalTrials.gov Identifier: NCT02226822
Recruitment Status : Active, not recruiting
First Posted : August 27, 2014
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This study is intended to prospectively research the treatment reality and long-term disease control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes treatment in sites across Japan.

Condition or disease
Type 2 Diabetes Mellitus

Detailed Description:
This study is a single country, multicenter, observational, prospective, longitudinal cohort study which will include adult patients with documented history of T2DM who are initiating a second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic therapy in real world setting. The follow-up period is 3 years. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Study Type : Observational
Actual Enrollment : 1869 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: J-DISCOVER: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan
Actual Study Start Date : September 20, 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Adult patients with documented T2DM
Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy



Primary Outcome Measures :
  1. Classes of diabetic medications at baseline and changes up to 3 years [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period.


Secondary Outcome Measures :
  1. Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in HbA1c from baseline, achievement rate of HbA1c and blood glucose target goals

  2. Blood glucose level change from baseline [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood glucose level (FPG or CPG or PPG) from baseline.

  3. Body weight change from baseline [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in body weight.

  4. Blood pressure change from baseline [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood pressure from baseline.

  5. Lipid profile changes from baseline [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in lipid profile

  6. Incidence of microvascular complications [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, disease progression in terms of microvascular complications: incidence of chronic nephropathy, dialysis, diabetic retinopathy, retinal photocoagulation, amputation of lower extremity, diabetic foot, peripheral nerve disorders, autonomic nervous system disorders and erectile dysfunction.

  7. Hypoglycemia events [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations

  8. Patient reported Quality of Life, diet, and physical activity level [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, patient reported Quality of Life, diet, and physical activity level

  9. Initiation of insulin therapy, Proportion of patients using insulin [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Initiation of insulin therapy (e.g., reporting the average number of anti-diabetic therapies prescribed as insulin therapy is initiated and dose of insulin)

  10. Switching of anti-diabetic medications or dose change [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Switching of anti-diabetic medications or dose change

  11. Initiation of third line or above add-on anti-diabetic medications [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Initiation of third line or above add-on anti-diabetic medication (e.g., reporting proportion of patients receiving 2nd, 3rd, 4th or greater anti-diabetic therapies at each follow-up visit)

  12. Incidence of macrovascular complications [ Time Frame: At 6, 12, 24, 36 month from enrollment ]
    Overall and by second line anti-diabetic medication class, disease progression in terms of macrovascular complications (heart failure, myocardial infarction and stroke).

  13. Risk factors [ Time Frame: At 6, 12, 24, 36 month after enrollment ]
    Risk factors (patient characteristics at baseline: e.g. age, gender, duration of diabetes, presence of co-morbidities) associated with poorer clinical outcomes during follow-up

  14. Treatment choice [ Time Frame: At baseline ]
    Determinants of treatment choice



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy
Criteria

Inclusion Criteria:

  1. Written consent obtained
  2. Aged > = 20 years
  3. Diagnosed with type 2 diabetes mellitus
  4. Initiating a second oral or parenteral anti-diabetic therapy added to oral anti-diabetic monotherapy or switching from the monotherapy to another monotherapy with different drug class

Exclusion Criteria:

  1. Diagnosis of Type 1 Diabetes Mellitus
  2. Current pregnancy
  3. Current treatment for any cancer
  4. Current dialysis treatment or renal transplantation
  5. Current treatment with any oral steroids
  6. Participation in any randomized control trials
  7. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker who does not understand the local language where interpreter are not available, psychiatric disturbances, alcohol or drug abuse).

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): NCT02226822


  Show 107 Study Locations
Sponsors and Collaborators
AstraZeneca
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Kiyoshi Hashigami, M.D. AstraZeneca K.K.
Principal Investigator: Iichiro Shimomura, M.D., Ph.D. Department of Metabolic Medicine (Internal Medicine), Graduate School of Medicine, Osaka University
Principal Investigator: Hirotaka Watada, M.D., Ph.D. Department of Metabolism & Endocrinology, Graduate School of Medicine, Juntendo University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02226822     History of Changes
Other Study ID Numbers: D1692R00001
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by AstraZeneca:
Type 2 diabetes mellitus

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