Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®

November 21, 2023 updated by: Novo Nordisk A/S

Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®. A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Ozempic® (Semaglutide) in Japanese Patients With Type 2 Diabetes Mellitus Under Normal Clinical Practice Condition

The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo Nordisk from their doctors in case of severe allergic reaction that might be caused by Ozempic®.

Study Overview

Status

Enrolling by invitation

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Drug: semaglutide

Study Type

Observational

Enrollment (Estimated)

3000

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
- - Aichi, Japan, 468-0009
    - Novo Nordisk Investigational Site
  - Aichi, Japan, 441-8087
    - Novo Nordisk Investigational Site
  - Aichi, Japan, 443-0022
    - Novo Nordisk Investigational Site
  - Aichi, Japan, 446-0044
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  - Aichi, Japan, 448-0852
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  - Aichi, Japan, 450-0002
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  - Aichi, Japan, 451-8511
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  - Aichi, Japan, 455-0815
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  - Aichi, Japan, 455-0857
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  - Aichi, Japan, 458-0011
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  - Aichi, Japan, 462-0037
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  - Aichi, Japan, 462-0047
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  - Aichi, Japan, 470-0345
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  - Aichi, Japan, 472-0014
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  - Aichi, Japan, 476-0011
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  - Aichi, Japan, 484-0066
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  - Aichi, Japan, 485-0044
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  - Aichi, Japan, 489-8642
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  - Akita, Japan, 016-0014
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  - Akita, Japan, 017-8550
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  - Akita, Japan, 018-4301
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  - Aomori, Japan, 030-0823
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  - Aomori, Japan, 038-0011
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  - Arakawa-ku, Tokyo, Japan, 116-0012
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  - Asahikawa-shi, Hokkaido, Japan, 078-8211
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  - Chiba, Japan, 299-1144
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  - Chiba, Japan, 264-0017
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  - Chiba, Japan, 271-0044
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  - Chiba, Japan, 272-0033
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  - Chiba, Japan, 274-0063
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  - Chiba, Japan, 274-0805
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  - Chiba, Japan, 277-0084
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  - Chiba, Japan, 277-8567
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  - Chiba, Japan, 279-0001
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  - Chiba, Japan, 283-0811
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  - Chiba, Japan, 286-0221
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  - Chiba, Japan, 290-0512
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  - Chiba, Japan, 292-0822
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  - Chiba, Japan, 295-0021
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  - Chiba-shi, Chiba, Japan, 260-0804
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  - Chichibu-city, Japan, 368-0004
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  - Chitose, Hokkaido, Japan, 066-0032
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  - Ehime, Japan, 791-0281
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  - Ehime, Japan, 790-0026
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  - Ehime, Japan, 790-0034
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  - Ehime, Japan, 791-8001
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  - Ehime, Japan, 791-8016
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  - Ehime, Japan, 791-8026
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  - Ehime, Japan, 792-0042
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  - Ehime, Japan, 792-8586
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  - Ehime, Japan, 794-0054
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  - Ehime, Japan, 798-8510
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  - Ehime, Japan, 799-0193
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  - Fukui, Japan, 910-0003
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  - Fukui-shi, Fukui, Japan, 918-8503
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  - Fukuoka, Japan, 800-0296
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  - Fukuoka, Japan, 803-0845
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  - Fukuoka, Japan, 804-0062
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  - Fukuoka, Japan, 805-0031
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  - Fukuoka, Japan, 807-1112
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  - Fukuoka, Japan, 8100001
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  - Fukuoka, Japan, 811-2122
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  - Fukuoka, Japan, 811-3217
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  - Fukuoka, Japan, 812-0053
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  - Fukuoka, Japan, 815-0033
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  - Fukuoka, Japan, 815-0071
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  - Fukuoka, Japan, 818-0072
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  - Fukuoka, Japan, 819-1102
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  - Fukuoka, Japan, 820-0076
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  - Fukuoka, Japan, 825-0002
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  - Fukuoka, Japan, 832-0032
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  - Fukuoka, Japan, 833-0041
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  - Fukuoka, Japan, 834-0115
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  - Fukuoka-shi, Fukuoka, Japan, 819-0006
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  - Fukushima, Japan, 961-8031
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  - Fukushima, Japan, 965-0853
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  - Fukushima, Japan, 973-8402
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  - Fukushima-shi, Fukushima, Japan, 960-8001
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  - Gifu, Japan, 500-8381
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  - Gifu, Japan, 501-6003
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  - Gifu, Japan, 501-6018
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  - Gifu, Japan, 501-6062
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  - Gifu, Japan, 504-0829
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  - Gifu, Japan, 506-0053
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  - Gifu-shi, Gifu, Japan, 501-1194
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  - Gumma, Japan, 370-3573
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  - Gumma, Japan, 372-0007
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  - Gumma, Japan, 372-0812
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  - Gumma, Japan, 373-0852
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  - Gunma, Japan, 373-0036
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  - Gunma, Japan, 370-0069
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  - Gunma, Japan, 374-0052
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  - Higashiosaka-shi, Osaka, Japan, 577 0803
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  - Hiroshima, Japan, 720-1131
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  - Hiroshima, Japan, 722-0002
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  - Hiroshima, Japan, 722-0014
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  - Hiroshima, Japan, 730-8619
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  - Hiroshima, Japan, 733-0033
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  - Hiroshima, Japan, 739-0041
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  - Hokkaido, Japan, 041-0821
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  - Hokkaido, Japan, 047-0021
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 053-0042
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  - Hokkaido, Japan, 060-0004
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 060-0042
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  - Hokkaido, Japan, 060-0807
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  - Hokkaido, Japan, 063-0005
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 064-0824
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  - Hokkaido, Japan, 064-0917
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 068-0021
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 070-8530
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 073-1105
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 078-8234
    - Novo Nordisk Investigational Site
  - Hokkaido, Japan, 080 0810
    - Novo Nordisk Investigational Site
  - Hosu-gun, Ishikawa, Japan, 927-0053
    - Novo Nordisk Investigational Site
  - Hyogo, Japan, 650-0002
    - Novo Nordisk Investigational Site
  - Hyogo, Japan, 651-2135
    - Novo Nordisk Investigational Site
  - Hyogo, Japan, 656-0026
    - Novo Nordisk Investigational Site
  - Hyogo, Japan, 658-0064
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  - Hyogo, Japan, 658-0084
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  - Hyogo, Japan, 659-8502
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  - Hyogo, Japan, 660-0861
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  - Hyogo, Japan, 660-0892
    - Novo Nordisk Investigational Site
  - Hyogo, Japan, 661-0976
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  - Hyogo, Japan, 662-0075
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  - Hyogo, Japan, 665-0861
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  - Hyogo, Japan, 670-0053
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  - Hyogo, Japan, 670-0801
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  - Hyogo, Japan, 672-8035
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  - Hyogo, Japan, 673-0891
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  - Hyogo, Japan, 674-0063
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  - Hyogo, Japan, 675-0156
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  - Hyogo, Japan, 675-0314
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  - Hyogo, Japan, 675-1316
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  - Hyogo, Japan, 675-8555
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  - Hyogo, Japan, 678-0226
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  - Hyogo, Japan, 678-0232
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  - Hyogogoken, Japan, 670-0837
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  - Ibaraki, Japan, 311-0113
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  - Ibaraki, Japan, 300-0012
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  - Ibaraki, Japan, 300-0395
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  - Ibaraki, Japan, 300-0504
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  - Ibaraki, Japan, 306-0232
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  - Ibaraki, Japan, 309-1703
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  - Ibaraki, Japan, 310-0015
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  - Ibaraki, Japan, 314-0031
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  - Iruma-shi, Saitama, Japan, 358 0003
    - Novo Nordisk Investigational Site
  - Ishikawa, Japan, 920-0293
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  - Ishikawa, Japan, 920-0012
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  - Iwate, Japan, 020-0403
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  - Iwate, Japan, 021-0002
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  - Iwate, Japan, 024-0061
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  - Iwate, Japan, 028-3695
    - Novo Nordisk Investigational Site
  - Kagawa, Japan, 760-8557
    - Novo Nordisk Investigational Site
  - Kagawa, Japan, 761-1701
    - Novo Nordisk Investigational Site
  - Kagawa, Japan, 762-0038
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  - Kagawa, Japan, 765-0052
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  - Kagawa, Japan, 765-0071
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  - Kagawa, Japan, 769-2401
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  - Kagoshima, Japan, 890-0073
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  - Kagoshima, Japan, 891-0133
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  - Kagoshima, Japan, 893-0014
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  - Kagoshima, Japan, 893-0022
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  - Kagoshima, Japan, 895-0052
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  - Kagoshima, Japan, 899-0214
    - Novo Nordisk Investigational Site
  - Kagoshima, Japan, 899-5421
    - Novo Nordisk Investigational Site
  - Kagoshima-shi, Kagoshima, Japan, 890-0061
    - Novo Nordisk Investigational Site
  - Kanagawa, Japan, 235-0045
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  - Kanagawa, Japan, 247-0055
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  - Kanagawa, Japan, 253-0042
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  - Kanagawa, Japan, 211-0004
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  - Kanagawa, Japan, 211-0041
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  - Kanagawa, Japan, 213-8507
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  - Kanagawa, Japan, 214-0014
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  - Kanagawa, Japan, 222-0033
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  - Kanagawa, Japan, 223-0052
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  - Kanagawa, Japan, 231-8682
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  - Kanagawa, Japan, 236-0033
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  - Kanagawa, Japan, 236-0037
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  - Kanagawa, Japan, 236-0058
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  - Kanagawa, Japan, 243-0035
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  - Kanagawa, Japan, 245-8575
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  - Kanagawa, Japan, 250-8558
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  - Kanagawa, Japan, 251-0052
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  - Kanagawa, Japan, 252-0131
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  - Kanagawa, Japan, 252-0302
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  - Kanagawa, Japan, 254-8502
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  - Kanagawa, Japan, 256-0816
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  - Kanagawa, Japan, 259-1126
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  - Kanagawa, Japan, 259-1193
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  - Kisarazu-shi, Chiba, Japan, 292-0038
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  - Kobe, Hyogo, Japan, 650-0017
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  - Kochi, Japan, 780-0843
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  - Koshigaya-shi,Saitama, Japan, 343 0828
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  - Kumamoto, Japan, 865-0064
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  - Kumamoto, Japan, 867-0041
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  - Kyoto, Japan, 601-8325
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  - Kyoto, Japan, 604-0884
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  - Kyoto, Japan, 604-8416
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  - Kyoto, Japan, 606-0025
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  - Kyoto, Japan, 607-8494
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  - Kyoto, Japan, 612-0875
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  - Kyoto, Japan, 619-0224
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  - Kyoto, Japan, 623-0011
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  - Mie, Japan, 514-8507
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  - Mie, Japan, 514-1101
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  - Mie, Japan, 516-0035
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  - Mie, Japan, 516-8512
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  - Mitaka-shi, Tokyo, Japan, 181-0013
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  - Miura-shi, Kanagawa, Japan, 238-0101
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  - Miyagi, Japan, 981-3133
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  - Miyagi, Japan, 982-0011
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  - Miyagi, Japan, 985-0863
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  - Miyagi, Japan, 988-0084
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  - Miyazaki, Japan, 880-0041
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  - Miyazaki, Japan, 880-0806
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  - Miyazaki, Japan, 889-3141
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  - Miyazaki, Japan, 889-4505
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  - Muroran-shi, Hokkaido, Japan, 050-0073
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  - Nagano, Japan, 385-8558
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  - Nagano, Japan, 386-0004
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  - Nagano, Japan, 386-8610
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  - Nagano, Japan, 395-8502
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  - Nagano, Japan, 395-8522
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  - Nagano, Japan, 396-0033
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  - Nagasaki, Japan, 850-0003
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  - Nagasaki, Japan, 850-0831
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  - Nagasaki, Japan, 851-0405
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  - Nagasaki, Japan, 852-8042
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  - Nagasaki, Japan, 852-8107
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  - Nagasaki, Japan, 852-8511
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  - Nagasaki, Japan, 856-0831
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  - Nagasaki, Japan, 857-8511
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  - Nara, Japan, 631-0003
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  - Nara, Japan, 631-0036
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  - Nara, Japan, 631-0813
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  - Nara, Japan, 631-0842
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  - Nara, Japan, 633-0064
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  - Nara, Japan, 635-0015
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  - Nara, Japan, 635-0825
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  - Nara, Japan, 636-0081
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  - Nara, Japan, 639-2251
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  - Niigata, Japan, 942-0052
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  - Niigata, Japan, 943-0893
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  - Niigata, Japan, 949-3443
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  - Niigata, Japan, 959-3193
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  - Niigata-shi, Niigata, Japan, 950-1104
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  - Nishinomiya-shi, Hyogo, Japan, 663-8501
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  - Oita, Japan, 870 8511
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  - Oita, Japan, 879-7301
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  - Oita, Japan, 870-0935
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  - Oita, Japan, 875-0051
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  - Oita, Japan, 879-0627
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  - Okayama, Japan, 700-8558
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  - Okayama, Japan, 708-0806
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  - Okayama, Japan, 710-0051
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  - Okayama, Japan, 711-0923
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  - Okayama, Japan, 714-0043
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  - Okayama-shi, Okayama, Japan, 701-1192
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  - Okinawa, Japan, 901-2131
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  - Okinawa, Japan, 902-0062
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  - Okinawa, Japan, 904-2143
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  - Okinawa, Japan, 904-2244
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  - Okinawa, Japan, 905-0018
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  - Osaka, Japan, 534-0021
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  - Osaka, Japan, 553-0003
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  - Osaka, Japan, 591-8006
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  - Osaka, Japan, 530-0004
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  - Osaka, Japan, 530-0012
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  - Osaka, Japan, 533-0001
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  - Osaka, Japan, 536-0002
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  - Osaka, Japan, 540-0006
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  - Osaka, Japan, 543-0014
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  - Osaka, Japan, 543-0035
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  - Osaka, Japan, 545-8586
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  - Osaka, Japan, 553-0002
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  - Osaka, Japan, 558-0013
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  - Osaka, Japan, 558-8558
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  - Osaka, Japan, 561-0833
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  - Osaka, Japan, 561-0884
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  - Osaka, Japan, 563-0033
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  - Osaka, Japan, 565-0842
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  - Osaka, Japan, 565-0874
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  - Osaka, Japan, 567-0886
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  - Osaka, Japan, 569-0804
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  - Osaka, Japan, 569-8585
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  - Osaka, Japan, 570-8540
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  - Osaka, Japan, 575-8511
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  - Osaka, Japan, 577-0802
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  - Osaka, Japan, 581-0869
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  - Osaka, Japan, 598-0011
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  - Osaka, Japan, 599-0202
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  - Osaka, Japan, 599-8233
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  - Osaka, Japan, 599-8247
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  - Osaka-shi, Osaka, Japan, 532 0003
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  - Osaka-shi, Osaka, Japan, 533-0024
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  - Osaka-shi, Osaka, Japan, 536-0001
    - Novo Nordisk Investigational Site
  - Osaki-shi, Miyagi, Japan, 989-6183
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  - Ota-ku, Tokyo, Japan, 1430015
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  - Ota-ku, Tokyo, Japan, 144-0051
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  - Saga, Japan, 843-0024
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  - Saga, Japan, 845-0013
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  - Saga, Japan, 847-0012
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  - Saga, Japan, 847-0062
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  - Saga, Japan, 847-8588
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  - Saga, Japan, 849-8577
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 330-0074
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 330-0846
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  - Saitama, Japan, 330-0855
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  - Saitama, Japan, 331-0811
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  - Saitama, Japan, 350-1231
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 350-2201
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 352-0035
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 356-0004
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 356-0057
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 359-1111
    - Novo Nordisk Investigational Site
  - Saitama, Japan, 368-0072
    - Novo Nordisk Investigational Site
  - Sendai-shi, Miyagi, Japan, 983-0824
    - Novo Nordisk Investigational Site
  - Shiga, Japan, 520-0242
    - Novo Nordisk Investigational Site
  - Shiga, Japan, 520-0865
    - Novo Nordisk Investigational Site
  - Shiga, Japan, 523-0082
    - Novo Nordisk Investigational Site
  - Shiga, Japan, 526-8580
    - Novo Nordisk Investigational Site
  - Shimane, Japan, 690-0883
    - Novo Nordisk Investigational Site
  - Shimane, Japan, 691-0044
    - Novo Nordisk Investigational Site
  - Shimane, Japan, 698-0046
    - Novo Nordisk Investigational Site
  - Shimotsuga-gun, Tochigi, Japan, 321-0204
    - Novo Nordisk Investigational Site
  - Shimotsuke-shi, Tochigi, Japan, 329-0433
    - Novo Nordisk Investigational Site
  - Shinjuku-ku, Tokyo, Japan, 162-8655
    - Novo Nordisk Investigational Site
  - Shinjyuku-ku Tokyo, Japan, 160-0022
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 420-0853
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 410-0041
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 410-0822
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 411-0801
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 411-0816
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 430-0802
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 431-3113
    - Novo Nordisk Investigational Site
  - Shizuoka, Japan, 432-8580
    - Novo Nordisk Investigational Site
  - Shizuoka-city, Shizuoka, Japan, 420-8630
    - Novo Nordisk Investigational Site
  - Soka-shi, Saitama, Japan, 340-0034
    - Novo Nordisk Investigational Site
  - Suzaka-shi ,Nagano, Japan, 382-0091
    - Novo Nordisk Investigational Site
  - Tamana-shi, Kumamoto, Japan, 865 0016
    - Novo Nordisk Investigational Site
  - Tochigi, Japan, 323-0022
    - Novo Nordisk Investigational Site
  - Tochigi, Japan, 321-1271
    - Novo Nordisk Investigational Site
  - Tochigi, Japan, 326-0053
    - Novo Nordisk Investigational Site
  - Tokorozawa-shi,Saitama, Japan, 359-1141
    - Novo Nordisk Investigational Site
  - Tokushima, Japan, 770-0022
    - Novo Nordisk Investigational Site
  - Tokushima, Japan, 774-0014
    - Novo Nordisk Investigational Site
  - Tokushima, Japan, 779-3125
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 105-8471
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 190-0023
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 206-0033
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 143-8541
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 101-8643
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 102-0074
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 103-0007
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 1040061
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 105-0012
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 108-0071
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 108-8642
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 110-0015
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 110-0016
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 111-0032
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 116-0014
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 124-0025
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 125-8506
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 133-0051
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 135-0002
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 135-0042
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 135-8550
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 142-0042
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 143-0016
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 144-0052
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 145-0072
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 150-0013
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 153-0051
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 154-0017
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 155-0031
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 160-8488
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 165-8906
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 166-0004
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 176-8530
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 178-0063
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 178-0064
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 186-0002
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 192-0083
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 193-0998
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 194-0013
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 198-0042
    - Novo Nordisk Investigational Site
  - Tokyo, Japan, 203-0053
    - Novo Nordisk Investigational Site
  - Tomigusuku-shi, Okinawa, Japan, 901-0244
    - Novo Nordisk Investigational Site
  - Tottori, Japan, 680-0935
    - Novo Nordisk Investigational Site
  - Tottori, Japan, 683-8504
    - Novo Nordisk Investigational Site
  - Toyama, Japan, 939-0243
    - Novo Nordisk Investigational Site
  - Toyama-shi, Toyama, Japan, 930-0194
    - Novo Nordisk Investigational Site
  - Toyonaka-shi, Osaka, Japan, 560-0082
    - Novo Nordisk Investigational Site
  - Wakayama, Japan, 640-8558
    - Novo Nordisk Investigational Site
  - Yamagata, Japan, 990-8510
    - Novo Nordisk Investigational Site
  - Yamagata, Japan, 996-0035
    - Novo Nordisk Investigational Site
  - Yamaguchi, Japan, 740-0034
    - Novo Nordisk Investigational Site
  - Yamaguchi, Japan, 742-1102
    - Novo Nordisk Investigational Site
  - Yamaguchi, Japan, 756-0095
    - Novo Nordisk Investigational Site
  - Yamanashi, Japan, 405-0072
    - Novo Nordisk Investigational Site
  - Yanagawa-shi, Fukuoka, Japan, 832-0059
    - Novo Nordisk Investigational Site
  - Yokohama, Kanagawa, Japan, 222-0036
    - Novo Nordisk Investigational Site
- Fukushima, Japan
  - Koriyama-shi, Fukushima, Japan, Japan, 963-8851
    - Novo Nordisk Investigational Site
- Kanagawa
  - Yamato-shi, Kanagawa, Japan, 242-0004
    - Novo Nordisk Investigational Site
- Kanagawa, Japan
  - Kamakura-shi, Kanagawa, Japan, Japan, 247 0056
    - Novo Nordisk Investigational Site
  - Kawasaki-shi, Kanagawa, Japan, Japan, 212 0024
    - Novo Nordisk Investigational Site
- Kumamoto, Japan
  - Kumamoto-shi, Kumamoto, Japan, Japan, 862-0976
    - Novo Nordisk Investigational Site
- Miyazaki, Japan
  - Miyazaki-shi, Miyazaki, Japan, Japan, 880-0034
    - Novo Nordisk Investigational Site
- Oita, Japan
  - Oita-shi, Oita, Japan, Japan, 870 0039
    - Novo Nordisk Investigational Site
- Osaka, Japan
  - Izumisano-shi, Osaka, Japan, Japan, 598 0048
    - Novo Nordisk Investigational Site
- Saitama, Japan
  - Kawagoe-shi, Saitama, Japan, Japan, 350-0851
    - Novo Nordisk Investigational Site
- Tokyo, Japan
  - Minato-ku, Tokyo, Japan, Japan, 108 0073
    - Novo Nordisk Investigational Site
- Toyama, Japan
  - Imizu-shi, Toyama, Japan, Japan, 939 0363
    - Novo Nordisk Investigational 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

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Japanese people with type 2 diabetes being treated in normal clinical practice conditions

Description

Inclusion Criteria:

Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
The decision to initiate treatment with commercially available Ozempic® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
Patients with Diabetes Mellitus, Type 2 (T2DM) who the physician has decided to start treatment with Ozempic®.
Male or female, no age limitation.

Exclusion Criteria:

Previous participation in this study. Participation is defined as having given informed consent in this study.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Patients who fall under contraindications to the label.
Patients who are or have previously been treated with Ozempic®.
Female who is pregnant, breast-feeding or intends to become pregnant.

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

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ozempic® Japanese people with type 2 diabetes being treated in normal clinical practice conditions	Drug: semaglutide Patients will be treated with commercially available Ozempic® according to routine clinical practice at the discretion of the treating physician. The treating physician's decision to initiate treatment with Ozempic® is independent of the decision to include the patient in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events (AEs) Time Frame: From baseline (day 0) to end of study (month 36)	Count	From baseline (day 0) to end of study (month 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of serious adverse reactions (SARs) Time Frame: From baseline (day 0) to end of study (month 36)	Count	From baseline (day 0) to end of study (month 36)
Number of adverse reactions (ARs) Time Frame: From baseline (day 0) to end of study (month 36)	Count	From baseline (day 0) to end of study (month 36)
Number of serious adverse events (SAEs) Time Frame: From baseline (day 0) to end of study (month 36)	Count	From baseline (day 0) to end of study (month 36)
Change in glycosylated haemoglobin A1c (HbA1c) Time Frame: From baseline (day 0) to end of study (month 36)	Percent	From baseline (day 0) to end of study (month 36)
Change in fasting plasma glucose (FPG) Time Frame: From baseline (day 0) to end of study (month 36)	mg/dL	From baseline (day 0) to end of study (month 36)
Change in body weight Time Frame: From baseline (day 0) to end of study (month 36)	kg	From baseline (day 0) to end of study (month 36)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score Time Frame: From baseline (day 0) to visit 5 (month 12)	DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree)	From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities Time Frame: From baseline (day 0) to visit 5 (month 12)	DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree)	From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment Time Frame: From baseline (day 0) to visit 5 (month 12)	DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree)	From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia Time Frame: From baseline (day 0) to visit 5 (month 12)	DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree)	From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment Time Frame: From baseline (day 0) to visit 5 (month 12)	DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree)	From baseline (day 0) to visit 5 (month 12)

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

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)

July 27, 2020

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN9535-4347
U1111-1187-9072 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on semaglutide

Search Similar Trials

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