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NCT Number: NCT02226822

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Anjo, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: J-DISCOVER

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2014
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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