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

Type 2 Diabetes Mellitus Clinical Trial

— J-DISCOVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226822
• Other study ID #: D1692R00001
• Status: Completed
• Start date: September 20, 2014
• Est. completion date: February 12, 2019

Study information

• Verified date: February 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1869
• Est. completion date: February 12, 2019
• Est. primary completion date: February 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hypoglycemia events	Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations	At 6, 12, 24, 36 month from enrollment
Secondary	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
Secondary	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
Secondary	Switching of anti-diabetic medications or dose change	Switching of anti-diabetic medications or dose change	At 6, 12, 24, 36 month from enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	Treatment choice	Determinants of treatment choice	At baseline

External Links

•   redacted CSR synopsis