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 :
Completed
First Posted : August 27, 2014
Last Update Posted : February 7, 2020
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Condition or disease |
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Type 2 Diabetes Mellitus |
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 |
Actual Primary Completion Date : | February 12, 2019 |
Actual Study Completion Date : | February 12, 2019 |

Group/Cohort |
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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
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- 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.
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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)
- 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
- 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)
- 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).
- 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
- Treatment choice [ Time Frame: At baseline ]Determinants of treatment choice

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Written consent obtained
- Aged > = 20 years
- Diagnosed with type 2 diabetes mellitus
- 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:
- Diagnosis of Type 1 Diabetes Mellitus
- Current pregnancy
- Current treatment for any cancer
- Current dialysis treatment or renal transplantation
- Current treatment with any oral steroids
- Participation in any randomized control trials
- 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).

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

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 |
Other Study ID Numbers: |
D1692R00001 |
First Posted: | August 27, 2014 Key Record Dates |
Last Update Posted: | February 7, 2020 |
Last Verified: | February 2020 |
Type 2 diabetes mellitus |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |