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

NCT02226822 | Completed

• 1 other identifier: D1692R00001
• Study Type: observational
• Target: 1,869
• Locations: 1 country
• Sites: 106

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Hemoglobin A1c change 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

  At 6, 12, 24, 36 month from enrollment

• Body weight change from baseline

  At 6, 12, 24, 36 month from enrollment

• Blood pressure change from baseline

  At 6, 12, 24, 36 month from enrollment

• Lipid profile changes from baseline

  At 6, 12, 24, 36 month from enrollment

Study Arms (1)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (106)

Research Site

Anjo, Aichi-ken, Japan

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Anzai, Aichi-ken, Japan

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Komatsu, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Hirosaki, Aomori, Japan

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Funabashi, Chiba, Japan

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Kisarazu, Chiba, Japan

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Tateyama, Chiba, Japan

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Matsuyama, Ehime, Japan

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Ono, Fukui, Japan

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Itoshima, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurate-gun, Fukuoka, Japan

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Oguri, Fukuoka, Japan

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Ōnojō, Fukuoka, Japan

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Iwaki, Fukushima, Japan

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Shirakawa, Fukushima, Japan

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Isesaki, Gunma, Japan

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Kanra-gun, Gunma, Japan

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Shibukawa, Gunma, Japan

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Takasaki, Gunma, Japan

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Fukuyama, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Kamikawa, Hokkaido, Japan

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Muroran, Hokkaido, Japan

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Nakagawa, Hokkaido, Japan

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Otaru, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Tamba, Hyōgo, Japan

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Hitachi, Ibaraki, Japan

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Koga, Ibaraki, Japan

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Ushiku, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Komatsu, Ishikawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Kanoya, Kagoshima-ken, Japan

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Chigasaki, Kanagawa, Japan

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Hiratsuka, Kanagawa, Japan

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Isehara, Kanagawa, Japan

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Kamakura, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Hitoyoshi, Kumamoto, Japan

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Tamana, Kumamoto, Japan

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Ise, Mie-ken, Japan

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Tsu, Mie-ken, Japan

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Yokkaichi, Mie-ken, Japan

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Sendai, Miyagi, Japan

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Nichinan, Miyazaki, Japan

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Iida, Nagano, Japan

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Ueda, Nagano, Japan

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Kitakatsuragi-gun, Nara, Japan

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Jōetsu, Niigata, Japan

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Tomigusuku, Okinawa, Japan

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Urazoe, Okinawa, Japan

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Ikuno-ku, Osaka, Japan

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Kashihara, Osaka, Japan

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Sennan-gun, Osaka, Japan

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Toyonaka, Osaka, Japan

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Imari, Saga-ken, Japan

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Karatsu, Saga-ken, Japan

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Nishimatuura, Saga-ken, Japan

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Kasukabe, Saitama, Japan

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Sakado, Saitama, Japan

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Kouka, Shiga, Japan

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Kōka, Shiga, Japan

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Maibara, Shiga, Japan

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Ōtsu, Shiga, Japan

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Hamamatsu, Shizuoka, Japan

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Yaizu, Shizuoka, Japan

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Nasushiobara, Tochigi, Japan

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Oyama, Tochigi, Japan

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Shimotsuga-gun, Tochigi, Japan

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Edogawa-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Kita-ku, Tokyo, Japan

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Koganei, Tokyo, Japan

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Kokubunji, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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Iwade, Wakayama, Japan

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Nakami, Yamagata, Japan

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Ube, Yamaguchi, Japan

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Kofu, Yamanashi, Japan

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Chiba, Japan

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Fukui, Japan

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Fukuoka, Japan

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Gifu, Japan

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Hiroshima, Japan

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Kochi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Miyazaki, Japan

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Okayama, Japan

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Osaka, Japan

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Ōita, Japan

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Saga, Japan

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Shizuoka, Japan

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Tochigi, Japan

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Tokushima, Japan

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Yamagata, Japan

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Related Publications (11)

• 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.

  PMID: 37648382 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.

  PMID: 35857060 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.

  PMID: 35546275 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.

  PMID: 34962628 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.

  PMID: 32868349 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.

  PMID: 32504219 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.

  PMID: 31468637 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.

  PMID: 31297947 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.

  PMID: 31215715 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.

  PMID: 30486889 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.

  PMID: 29260460 DERIVED

Related Links

• redacted CSR synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: September 20, 2014
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

JP (106)