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

February 6, 2020 updated by: AstraZeneca

J-DISCOVER: 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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1869

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
        • Research Site
      • Fukui, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Gifu, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Miyazaki, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saga, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Tochigi, Japan
        • Research Site
      • Tokushima, Japan
        • Research Site
      • Yamagata, Japan
        • Research Site
    • Aichi
      • Anjo, Aichi, Japan
        • Research Site
      • Anzai, Aichi, Japan
        • Research Site
      • Komatsu, Aichi, Japan
        • Research Site
      • Nagoya, Aichi, Japan
        • Research Site
    • Aomori
      • Hirosaki, Aomori, Japan
        • Research Site
    • Chiba
      • Funabashi, Chiba, Japan
        • Research Site
      • Kisarazu, Chiba, Japan
        • Research Site
      • Tateyama, Chiba, Japan
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Research Site
    • Fukui
      • Ono, Fukui, Japan
        • Research Site
    • Fukuoka
      • Itoshima, Fukuoka, Japan
        • Research Site
      • Kitakyushu, Fukuoka, Japan
        • Research Site
      • Kurate-gun, Fukuoka, Japan
        • Research Site
      • Oguri, Fukuoka, Japan
        • Research Site
      • Onojo, Fukuoka, Japan
        • Research Site
    • Fukushima
      • Iwaki, Fukushima, Japan
        • Research Site
      • Shirakawa, Fukushima, Japan
        • Research Site
    • Gunma
      • Isesaki, Gunma, Japan
        • Research Site
      • Kanra-gun, Gunma, Japan
        • Research Site
      • Shibukawa, Gunma, Japan
        • Research Site
      • Takasaki, Gunma, Japan
        • Research Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
      • Hakodate, Hokkaido, Japan
        • Research Site
      • Kamikawa, Hokkaido, Japan
        • Research Site
      • Muroran, Hokkaido, Japan
        • Research Site
      • Nakagawa, Hokkaido, Japan
        • Research Site
      • Otaru, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Research Site
      • Kobe, Hyogo, Japan
        • Research Site
    • Hyougo
      • Kobe, Hyougo, Japan
        • Research Site
      • Tamba, Hyougo, Japan
        • Research Site
    • Ibaraki
      • Hitachi, Ibaraki, Japan
        • Research Site
      • Koga, Ibaraki, Japan
        • Research Site
      • Ushiku, Ibaraki, Japan
        • Research Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Research Site
      • Komatsu, Ishikawa, Japan
        • Research Site
    • Kagawa
      • Takamatsu, Kagawa, Japan
        • Research Site
    • Kagoshima
      • Kanoya, Kagoshima, Japan
        • Research Site
    • Kanagawa
      • Chigasaki, Kanagawa, Japan
        • Research Site
      • Hiratsuka, Kanagawa, Japan
        • Research Site
      • Isehara, Kanagawa, Japan
        • Research Site
      • Kamakura, Kanagawa, Japan
        • Research Site
      • Kawasaki, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Kumamoto
      • Hitoyoshi, Kumamoto, Japan
        • Research Site
      • Tamana, Kumamoto, Japan
        • Research Site
    • Mie
      • Ise, Mie, Japan
        • Research Site
      • Tsu, Mie, Japan
        • Research Site
      • Yokkaichi, Mie, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Miyazaki
      • Nichinan, Miyazaki, Japan
        • Research Site
    • Nagano
      • Iida, Nagano, Japan
        • Research Site
      • Ueda, Nagano, Japan
        • Research Site
    • Nara
      • Kitakatsuragi-gun, Nara, Japan
        • Research Site
    • Nigata
      • Joetsu, Nigata, Japan
        • Research Site
    • Okinawa
      • Tomigusuku, Okinawa, Japan
        • Research Site
      • Urazoe, Okinawa, Japan
        • Research Site
    • Osaka
      • Ikuno-ku, Osaka, Japan
        • Research Site
      • Kashiwara, Osaka, Japan
        • Research Site
      • Sennan-gun, Osaka, Japan
        • Research Site
      • Toyonaka, Osaka, Japan
        • Research Site
    • Saga
      • Imari, Saga, Japan
        • Research Site
      • Karatsu, Saga, Japan
        • Research Site
      • Nishimatuura, Saga, Japan
        • Research Site
    • Saitama
      • Kasukabe, Saitama, Japan
        • Research Site
      • Sakado, Saitama, Japan
        • Research Site
    • Shiga
      • Koka, Shiga, Japan
        • Research Site
      • Kouka, Shiga, Japan
        • Research Site
      • Maibara, Shiga, Japan
        • Research Site
      • Otsu, Shiga, Japan
        • Research Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
        • Research Site
      • Yaizu, Shizuoka, Japan
        • Research Site
    • Tochigi
      • Nasushiobara, Tochigi, Japan
        • Research Site
      • Oyama, Tochigi, Japan
        • Research Site
      • Shimotsuga-gun, Tochigi, Japan
        • Research Site
    • Tokyo
      • Edogawa-ku, Tokyo, Japan
        • Research Site
      • Hachioji, Tokyo, Japan
        • Research Site
      • Kita-ku, Tokyo, Japan
        • Research Site
      • Koganei, Tokyo, Japan
        • Research Site
      • Kokubunji, Tokyo, Japan
        • Research Site
      • Mitaka, Tokyo, Japan
        • Research Site
      • Nerima-ku, Tokyo, Japan
        • Research Site
      • Shinagawa-ku, Tokyo, Japan
        • Research Site
      • Shinjuku, Tokyo, Japan
        • Research Site
    • Wakayama
      • Iwade, Wakayama, Japan
        • Research Site
    • Yamagata
      • Mogami, Yamagata, Japan
        • Research Site
    • Yamaguchi
      • Ube, Yamaguchi, Japan
        • Research Site
    • Yamanashi
      • Koufu, Yamanashi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
At 6, 12, 24, 36 month from enrollment
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.
At 6, 12, 24, 36 month from enrollment
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.
At 6, 12, 24, 36 month from enrollment
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.
At 6, 12, 24, 36 month from enrollment
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
At 6, 12, 24, 36 month from enrollment
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.
At 6, 12, 24, 36 month from enrollment
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
At 6, 12, 24, 36 month from enrollment
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
At 6, 12, 24, 36 month from enrollment
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)
At 6, 12, 24, 36 month from enrollment
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
At 6, 12, 24, 36 month from enrollment
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)
At 6, 12, 24, 36 month from enrollment
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).
At 6, 12, 24, 36 month from enrollment
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
At 6, 12, 24, 36 month after enrollment
Treatment choice
Time Frame: At baseline
Determinants of treatment choice
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2014

Primary Completion (Actual)

February 12, 2019

Study Completion (Actual)

February 12, 2019

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1692R00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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