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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Kiyoshi Hashigami, M.D. | AstraZeneca | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anjo | Aichi-ken | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37648382 | Derived | Al Rubeaan K, Banah F, Alruwaily FG, Sheshah E, Alnaqeb D, AlQahtani AM, Ewais D, Al Juhani N, Hassan AH, Youssef AM. Metabolic control and incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy: an analysis of the Saudi Arabia data from the DISCOVER Observational Study programme. BMJ Open. 2023 Aug 30;13(8):e063586. doi: 10.1136/bmjopen-2022-063586. | |
| 35857060 |
| Label | URL |
|---|---|
| redacted CSR synopsis | View source |
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| 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 |
| Anzai |
| Aichi-ken |
| Japan |
| Research Site | Komatsu | Aichi-ken | Japan |
| Research Site | Nagoya | Aichi-ken | Japan |
| Research Site | Hirosaki | Aomori | Japan |
| Research Site | Funabashi | Chiba | Japan |
| Research Site | Kisarazu | Chiba | Japan |
| Research Site | Tateyama | Chiba | Japan |
| Research Site | Matsuyama | Ehime | Japan |
| Research Site | Ono | Fukui | Japan |
| Research Site | Itoshima | Fukuoka | Japan |
| Research Site | Kitakyushu | Fukuoka | Japan |
| Research Site | Kurate-gun | Fukuoka | Japan |
| Research Site | Oguri | Fukuoka | Japan |
| Research Site | Ōnojō | Fukuoka | Japan |
| Research Site | Iwaki | Fukushima | Japan |
| Research Site | Shirakawa | Fukushima | Japan |
| Research Site | Isesaki | Gunma | Japan |
| Research Site | Kanra-gun | Gunma | Japan |
| Research Site | Shibukawa | Gunma | Japan |
| Research Site | Takasaki | Gunma | Japan |
| Research Site | Fukuyama | Hiroshima | Japan |
| Research Site | 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 | Amagasaki | Hyōgo | Japan |
| Research Site | Kobe | Hyōgo | Japan |
| Research Site | Tamba | Hyōgo | Japan |
| Research Site | Hitachi | Ibaraki | Japan |
| Research Site | Koga | Ibaraki | Japan |
| Research Site | Ushiku | Ibaraki | Japan |
| Research Site | Kanazawa | Ishikawa-ken | Japan |
| Research Site | Komatsu | Ishikawa-ken | Japan |
| Research Site | Takamatsu | Kagawa-ken | Japan |
| Research Site | Kanoya | Kagoshima-ken | Japan |
| Research Site | 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 | Hitoyoshi | Kumamoto | Japan |
| Research Site | Tamana | Kumamoto | Japan |
| Research Site | Ise | Mie-ken | Japan |
| Research Site | Tsu | Mie-ken | Japan |
| Research Site | Yokkaichi | Mie-ken | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Nichinan | Miyazaki | Japan |
| Research Site | Iida | Nagano | Japan |
| Research Site | Ueda | Nagano | Japan |
| Research Site | Kitakatsuragi-gun | Nara | Japan |
| Research Site | Jōetsu | Niigata | Japan |
| Research Site | Tomigusuku | Okinawa | Japan |
| Research Site | Urazoe | Okinawa | Japan |
| Research Site | Ikuno-ku | Osaka | Japan |
| Research Site | Kashihara | Osaka | Japan |
| Research Site | Sennan-gun | Osaka | Japan |
| Research Site | Toyonaka | Osaka | Japan |
| Research Site | Imari | Saga-ken | Japan |
| Research Site | Karatsu | Saga-ken | Japan |
| Research Site | Nishimatuura | Saga-ken | Japan |
| Research Site | Kasukabe | Saitama | Japan |
| Research Site | Sakado | Saitama | Japan |
| Research Site | Kouka | Shiga | Japan |
| Research Site | Kōka | Shiga | Japan |
| Research Site | Maibara | Shiga | Japan |
| Research Site | Ōtsu | Shiga | Japan |
| Research Site | Hamamatsu | Shizuoka | Japan |
| Research Site | Yaizu | Shizuoka | Japan |
| Research Site | Nasushiobara | Tochigi | Japan |
| Research Site | Oyama | Tochigi | Japan |
| Research Site | Shimotsuga-gun | Tochigi | Japan |
| Research Site | Edogawa-ku | Tokyo | Japan |
| Research Site | Hachiōji | 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 | Iwade | Wakayama | Japan |
| Research Site | Nakami | Yamagata | Japan |
| Research Site | Ube | Yamaguchi | Japan |
| Research Site | Kofu | Yamanashi | Japan |
| Research Site | 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 | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Saga | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | Tochigi | Japan |
| Research Site | Tokushima | Japan |
| Research Site | Yamagata | Japan |
| Derived |
| 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. |
| 35546275 | Derived | 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. |
| 34962628 | Derived | 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. |
| 32868349 | Derived | 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. |
| 32504219 | Derived | 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. |
| 31468637 | Derived | 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. |
| 31297947 | Derived | 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. |
| 31215715 | Derived | 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. |
| 30486889 | Derived | 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. |
| 29260460 | Derived | 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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