Clinical trial NCT02226822: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan
Official title: J-DISCOVER: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2014-08-27
Enrollment: 1869
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Classes of diabetic medications at baseline and changes up to 3 years
timeFrame: At 6, 12, 24, 36 month from enrollment
Secondary outcomes:
measure: Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Blood glucose level change from baseline
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Body weight change from baseline
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Blood pressure change from baseline
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Lipid profile changes from baseline
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Incidence of microvascular complications
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Hypoglycemia events
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Patient reported Quality of Life, diet, and physical activity level
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Initiation of insulin therapy, Proportion of patients using insulin
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Switching of anti-diabetic medications or dose change
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Initiation of third line or above add-on anti-diabetic medications
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Incidence of macrovascular complications
timeFrame: At 6, 12, 24, 36 month from enrollment
measure: Risk factors
timeFrame: At 6, 12, 24, 36 month after enrollment
measure: Treatment choice
timeFrame: At baseline
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Research Site
state: Aichi
city: Anzai
country: Japan
facility: Research Site
state: Aichi
city: Komatsu
country: Japan
facility: Research Site
state: Aichi
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Hirosaki
country: Japan
facility: Research Site
state: Aomori
city: Funabashi
country: Japan
facility: Research Site
state: Chiba
city: Kisarazu
country: Japan
facility: Research Site
state: Chiba
city: Tateyama
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Ono
country: Japan
facility: Research Site
state: Fukui
city: Itoshima
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Research Site
state: Fukuoka
city: Kurate-gun
country: Japan
facility: Research Site
state: Fukuoka
city: Oguri
country: Japan
facility: Research Site
state: Fukuoka
city: Onojo
country: Japan
facility: Research Site
state: Fukuoka
city: Iwaki
country: Japan
facility: Research Site
state: Fukushima
city: Shirakawa
country: Japan
facility: Research Site
state: Fukushima
city: Isesaki
country: Japan
facility: Research Site
state: Gunma
city: Kanra-gun
country: Japan
facility: Research Site
state: Gunma
city: Shibukawa
country: Japan
facility: Research Site
state: Gunma
city: Takasaki
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Hakodate
country: Japan
facility: Research Site
state: Hokkaido
city: Kamikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Muroran
country: Japan
facility: Research Site
state: Hokkaido
city: Nakagawa
country: Japan
facility: Research Site
state: Hokkaido
city: Otaru
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Amagasaki
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyougo
city: Tamba
country: Japan
facility: Research Site
state: Hyougo
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Koga
country: Japan
facility: Research Site
state: Ibaraki
city: Ushiku
country: Japan
facility: Research Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Komatsu
country: Japan
facility: Research Site
state: Ishikawa
city: Takamatsu
country: Japan
facility: Research Site
state: Kagawa
city: Kanoya
country: Japan
facility: Research Site
state: Kagoshima
city: Chigasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Hiratsuka
country: Japan
facility: Research Site
state: Kanagawa
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Kamakura
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Hitoyoshi
country: Japan
facility: Research Site
state: Kumamoto
city: Tamana
country: Japan
facility: Research Site
state: Kumamoto
city: Ise
country: Japan
facility: Research Site
state: Mie
city: Tsu
country: Japan
facility: Research Site
state: Mie
city: Yokkaichi
country: Japan
facility: Research Site
state: Mie
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Nichinan
country: Japan
facility: Research Site
state: Miyazaki
city: Iida
country: Japan
facility: Research Site
state: Nagano
city: Ueda
country: Japan
facility: Research Site
state: Nagano
city: Kitakatsuragi-gun
country: Japan
facility: Research Site
state: Nara
city: Joetsu
country: Japan
facility: Research Site
state: Nigata
city: Tomigusuku
country: Japan
facility: Research Site
state: Okinawa
city: Urazoe
country: Japan
facility: Research Site
state: Okinawa
city: Ikuno-ku
country: Japan
facility: Research Site
state: Osaka
city: Kashiwara
country: Japan
facility: Research Site
state: Osaka
city: Sennan-gun
country: Japan
facility: Research Site
state: Osaka
city: Toyonaka
country: Japan
facility: Research Site
state: Osaka
city: Imari
country: Japan
facility: Research Site
state: Saga
city: Karatsu
country: Japan
facility: Research Site
state: Saga
city: Nishimatuura
country: Japan
facility: Research Site
state: Saga
city: Kasukabe
country: Japan
facility: Research Site
state: Saitama
city: Sakado
country: Japan
facility: Research Site
state: Saitama
city: Koka
country: Japan
facility: Research Site
state: Shiga
city: Kouka
country: Japan
facility: Research Site
state: Shiga
city: Maibara
country: Japan
facility: Research Site
state: Shiga
city: Otsu
country: Japan
facility: Research Site
state: Shiga
city: Hamamatsu
country: Japan
facility: Research Site
state: Shizuoka
city: Yaizu
country: Japan
facility: Research Site
state: Shizuoka
city: Nasushiobara
country: Japan
facility: Research Site
state: Tochigi
city: Oyama
country: Japan
facility: Research Site
state: Tochigi
city: Shimotsuga-gun
country: Japan
facility: Research Site
state: Tochigi
city: Edogawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Hachioji
country: Japan
facility: Research Site
state: Tokyo
city: Kita-ku
country: Japan
facility: Research Site
state: Tokyo
city: Koganei
country: Japan
facility: Research Site
state: Tokyo
city: Kokubunji
country: Japan
facility: Research Site
state: Tokyo
city: Mitaka
country: Japan
facility: Research Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Iwade
country: Japan
facility: Research Site
state: Wakayama
city: Mogami
country: Japan
facility: Research Site
state: Yamagata
city: Ube
country: Japan
facility: Research Site
state: Yamaguchi
city: Koufu
country: Japan
facility: Research Site
state: Yamanashi
city: Chiba
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Kiyoshi Hashigami, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Metabolic Medicine (Internal Medicine), Graduate School of Medicine, Osaka University
name: Iichiro Shimomura, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Metabolism & Endocrinology, Graduate School of Medicine, Juntendo University
name: Hirotaka Watada, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mita T, Katakami N, Takahara M, Kawashima M, Wada F, Akiyama H, Morita N, Kidani Y, Yajima T, Shimomura I, Watada H. Changes in Treatment Satisfaction Over 3 Years in Patients With Type 2 Diabetes After Initiating Second-line Treatment. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2424-2432. doi: 10.1210/clinem/dgac420.
citation: Hejjaji V, Gorgojo-Martinez JJ, Tang F, Garnelo JB, Cooper A, Medina J, Mutiozabal MS, Khunti K, Nicolucci A, Shestakova MV, Ji L, Gomes MB, Watada H, Vora J, Malik AO, Kosiborod M, Arnold SV. Factors associated with weight loss in people with overweight or obesity living with type 2 diabetes mellitus: Insights from the global DISCOVER study. Diabetes Obes Metab. 2022 Sep;24(9):1734-1740. doi: 10.1111/dom.14745. Epub 2022 May 25.
citation: Takahara M, Mita T, Katakami N, Wada F, Morita N, Kidani Y, Yajima T, Shimomura I, Watada H; J-DISCOVER study group. Three-Year Glycaemic Control and Management in Patients with Type 2 Diabetes Initiating Second-Line Treatment in Japan: A Prospective Observational Study, J-DISCOVER. Diabetes Ther. 2022 Feb;13(2):251-264. doi: 10.1007/s13300-021-01192-x. Epub 2021 Dec 28.
citation: Khunti K, Gomes MB, Kosiborod M, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Tang F, Ji L; DISCOVER Scientific Committee and all DISCOVER investigators. Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme. BMJ Open. 2020 Aug 30;10(8):e034613. doi: 10.1136/bmjopen-2019-034613.
citation: Katakami N, Mita T, Takahara M, Yajima T, Wada F, Kawashima M, Shimomura I, Watada H; J-DISCOVER Study Group. Baseline Characteristics of Patients with Type 2 Diabetes Initiating Second-Line Treatment in Japan: Findings from the J-DISCOVER Study. Diabetes Ther. 2020 Jul;11(7):1563-1578. doi: 10.1007/s13300-020-00846-6. Epub 2020 Jun 5.
citation: Khunti K, Chen H, Cid-Ruzafa J, Fenici P, Gomes MB, Hammar N, Ji L, Kosiborod M, Pocock S, Shestakova MV, Shimomura I, Tang F, Watada H, Nicolucci A; DISCOVER investigators. Glycaemic control in patients with type 2 diabetes initiating second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2020 Jan;22(1):66-78. doi: 10.1111/dom.13866. Epub 2019 Oct 1.
citation: Nicolucci A, Charbonnel B, Gomes MB, Khunti K, Kosiborod M, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Pocock S. Treatment patterns and associated factors in 14 668 people with type 2 diabetes initiating a second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2474-2485. doi: 10.1111/dom.13830. Epub 2019 Aug 5.
citation: Khunti K, Ji L, Medina J, Surmont F, Kosiborod M. Type 2 diabetes treatment and outcomes worldwide: A short review of the DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2349-2353. doi: 10.1111/dom.13817. Epub 2019 Jul 14.
citation: Kosiborod M, Gomes MB, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Watada H, Shimomura I, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Khunti K; DISCOVER investigators. Vascular complications in patients with type 2 diabetes: prevalence and associated factors in 38 countries (the DISCOVER study program). Cardiovasc Diabetol. 2018 Nov 28;17(1):150. doi: 10.1186/s12933-018-0787-8.
citation: Katakami N, Mita T, Takahara M, Hashigami K, Kawashima M, Shimomura I, Watada H; J-DISCOVER study group. Rationale and Design for the J-DISCOVER Study: DISCOVERing the Treatment Reality of Type 2 Diabetes in a Real-World Setting in Japan-A Protocol. Diabetes Ther. 2018 Feb;9(1):165-175. doi: 10.1007/s13300-017-0351-7. Epub 2017 Dec 19.