DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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J-DISCOVER: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan

Conditions
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Type 2 Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients with documented T2DM<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classes of diabetic medications at baseline and changes up to 3 years | Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period. | At 6, 12, 24, 36 month from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals | 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 | At 6, 12, 24, 36 month from enrollment | 
| Blood glucose level change from baseline | 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. | At 6, 12, 24, 36 month from enrollment | 
| Body weight change from baseline | Overall and by second line anti-diabetic medication class, treatment response in terms of changes in body weight. | At 6, 12, 24, 36 month from enrollment | 
| Blood pressure change from baseline | Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood pressure from baseline. | At 6, 12, 24, 36 month from enrollment | 
| Lipid profile changes from baseline | Overall and by second line anti-diabetic medication class, treatment response in terms of changes in lipid profile | At 6, 12, 24, 36 month from enrollment | 
| Incidence of microvascular complications | 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. | At 6, 12, 24, 36 month from enrollment | 
| Hypoglycemia events | Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations | At 6, 12, 24, 36 month from enrollment | 
| Patient reported Quality of Life, diet, and physical activity level | Overall and by second line anti-diabetic medication class, patient reported Quality of Life, diet, and physical activity level | At 6, 12, 24, 36 month from enrollment | 
| Initiation of insulin therapy, Proportion of patients using insulin | Initiation of insulin therapy (e.g., reporting the average number of anti-diabetic therapies prescribed as insulin therapy is initiated and dose of insulin) | At 6, 12, 24, 36 month from enrollment | 
| Switching of anti-diabetic medications or dose change | Switching of anti-diabetic medications or dose change | At 6, 12, 24, 36 month from enrollment | 
| Initiation of third line or above add-on anti-diabetic medications | 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) | At 6, 12, 24, 36 month from enrollment | 
| Incidence of macrovascular complications | Overall and by second line anti-diabetic medication class, disease progression in terms of macrovascular complications (heart failure, myocardial infarction and stroke). | At 6, 12, 24, 36 month from enrollment | 
| Risk factors | 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 | At 6, 12, 24, 36 month after enrollment | 
| Treatment choice | Determinants of treatment choice | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus