AzTrials
AzTrials

Diabetes Mellitus, Type 2NCT04469855

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

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 414 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
semaglutide
How many people
3,217 participants
Where
414 sitesJapan
Study dates
27 Jul 2020to 12 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

414 sites in 1 country.

300 sites in 1 country

Japan300 sites

  • Yamauchi Family Clinic

    Aichi, 441-8087

  • Kobayashi Naika Clinic

    Aichi, 443-0022

  • Wakaba Clinic

    Aichi, 446-0044

  • Miyachi Clinic

    Aichi, 448-0852

  • Meiekihigashi Clinic

    Aichi, 450-0002

  • Meitetsu Hospital_Endocrinology and Metabolism

    Aichi, 451-8511

  • Kusama Minato Clinic

    Aichi, 455-0815

  • Nagashima Naika

    Aichi, 455-0857

  • Aikawa Minnano Shinryojo

    Aichi, 458-0011

  • Nakai Internal Clinic

    Aichi, 462-0037

  • Takenaka Clinic

    Aichi, 462-0047

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009

  • Enomoto Naika

    Aichi, 470-0345

  • Sawayaka Medical Clinic

    Aichi, 472-0014

  • Ogawa Clinic_Aichi

    Aichi, 476-0011

  • Inuyama Chuo General Hospital_Diabetes Internal Medicine

    Aichi, 484-0066

  • Uenishi Internal Medicine Clinic

    Aichi, 485-0044

  • Tosei General Hospital_Endocrinology and Metabolism

    Aichi, 489-8642

  • Noshiro Kosei Iryo Center_Diabetes and Metabolism

    Akita, 016-0014

  • Odate Municipal General Hospital_Endocrinology and Metabolism

    Akita, 017-8550

  • Kitaakita Shiritsu Yonaizawa Shinryojo

    Akita, 018-4301

  • Ohisama Clinic_Aomori

    Aomori, 030-0823

  • Kakizaki Tonyobyo Naika Clinic

    Aomori, 038-0011

  • Kumanomae Nishimura Naika Clinic_Internal Medicine

    Arakawa-ku, Tokyo, 116-0012

  • Shimizu internal medicine clinic

    Asahikawa-shi, Hokkaido, 078-8211

  • Chiba Central Medical Center

    Chiba, 264-0017

  • Shimada Iin

    Chiba, 271-0044

  • Ichikawaekimae Ogawa Naika

    Chiba, 272-0033

  • Endo Naika

    Chiba, 274-0063

  • Misaki Naika Clinic

    Chiba, 274-0805

  • Shinkashiwa Clinic Tonyobyomirai

    Chiba, 277-0084

  • The Jikei University Kashiwa Hospital_Diabetes and Endocrinology

    Chiba, 277-8567

  • Tokyo Bay Urayasu Ichikawa Medical Center_Neph.& Endocrinology, Diabetes

    Chiba, 279-0001

  • Saito Clinic

    Chiba, 283-0811

  • Toyo Clinic

    Chiba, 286-0221

  • Chiba Cerebral and Cardiovascular Center

    Chiba, 290-0512

  • Kimitsu Chuo Hospital_Diabetology and Endocrinology

    Chiba, 292-0822

  • Matsunaga Iin

    Chiba, 295-0021

  • Gengendo Kimitsu Hospital_Diabetes and Endocrinology

    Chiba, 299-1144

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804

  • Mizuno Clinic

    Chichibu, 368-0004

  • Hasegawa Medicine Clinic, Internal medicine

    Chitose, Hokkaido, 066-0032

  • Soyokaze CardioVascular Medicine and Diabetes Care

    Ehime, 790-0026

  • Mikannohana Clinic

    Ehime, 790-0034

  • Ehime Medical Center

    Ehime, 791-0281

  • Yoshino Internal Medicine

    Ehime, 791-8001

  • Matsuyama Daiichi Hospital_Diabetes Internal Medicine

    Ehime, 791-8016

  • Saiseikai Matsuyama Hospital_Internal Medicine

    Ehime, 791-8026

  • Ehime Prefectural Niihama Hp._Internal Medicine

    Ehime, 792-0042

  • Jyuzen General Hospital_Internal Medicine

    Ehime, 792-8586

  • Hoshasen Daiichi Byoin_Internal Medicine

    Ehime, 794-0054

  • Uwajima City Hospital_Endocrinology and Diabetes

    Ehime, 798-8510

  • Shikoku Central Hospital_Internal Medicine

    Ehime, 799-0193

  • Fukui Chuoh Clinic

    Fukui, 910-0003

  • Fukui Prefecture Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503

  • Kyushu Rosai Hospital_Diabetes and Metabolism

    Fukuoka, 800-0296

  • Kuroki Hiro Clinic

    Fukuoka, 803-0845

  • Hatanaka Naika Clinic

    Fukuoka, 804-0062

  • Minezaki Naika Clinic

    Fukuoka, 805-0031

  • Chiyo Clinic

    Fukuoka, 807-1112

  • Hayashida Internal Medicine Clinic

    Fukuoka, 8100001

  • Okabe Hospital_Internal Medicine

    Fukuoka, 811-2122

  • Fukutsu Naika Clinic

    Fukuoka, 811-3217

  • Okada Naika Clinic

    Fukuoka, 812-0053

  • Tojitama Thyroid and Diabetes Clinic

    Fukuoka, 815-0033

  • Clinic Masae Minami

    Fukuoka, 815-0071

  • Iino Naika

    Fukuoka, 818-0072

  • Kikuchi Naika Iin Maebaru

    Fukuoka, 819-1102

  • Iizuka Kaho Hospital_Internal Medicine

    Fukuoka, 820-0076

  • Kuwano Naika Shonika Iin

    Fukuoka, 825-0002

  • Ishibashi Iin

    Fukuoka, 832-0032

  • Chikugo Shiritsu Byoin_Endocrinology and Metabolism

    Fukuoka, 833-0041

  • Himeno Hospital

    Fukuoka, 834-0115

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006

  • Iwashina Clinic

    Fukushima, 961-8031

  • Aizu Clinic

    Fukushima, 965-0853

  • Taneda Clinic

    Fukushima, 973-8402

  • Tani Naika Clinic, Internal medicine and diabets

    Fukushima-shi, Fukushima, 960-8001

  • Yamauchi Hospital_Internal Medicine

    Gifu, 500-8381

  • Keyaki Clinic

    Gifu, 501-6003

  • Kitada Internal Medicine Clinic

    Gifu, 501-6018

  • Matsunami General Hospital_Diabetes and Endocrinology

    Gifu, 501-6062

  • Asano Naika

    Gifu, 504-0829

  • Ogawa Clinic_Gifu

    Gifu, 506-0053

  • Gifu University Hospital_The Third Dep of Internal Medicine

    Gifu-shi, Gifu, 501-1194

  • Shimizu Naika

    Gunma, 370-0069

  • Kawada Clinic

    Gunma, 373-0036

  • Goga Internal Medicine Nire Clinic

    Gunma, 374-0052

  • Takekawa clinic, Internal Medicine

    Higashiosaka-shi, Osaka, 577 0803

  • Sato Family Clinic

    Hiroshima, 720-1131

  • Tanabe Clinic

    Hiroshima, 722-0002

  • Murakami Memorial Hospital_Diabetes Internal Medicine

    Hiroshima, 722-0014

  • Hiroshima Red Cross & Atomic-b_Endocrinology and Metabolism

    Hiroshima, 730-8619

  • Hisayasu Iin

    Hiroshima, 733-0033

  • Higashihiroshima Medical Center_Endocrinology and Diabetes

    Hiroshima, 739-0041

  • Takasawa Diabetes Clinic

    Hokkaido, 041-0821

  • Nakagaki Primary Care Clinic

    Hokkaido, 047-0021

  • Ohata Naika Junkanki Clinic

    Hokkaido, 053-0042

  • Sapporo Tonyobyo Kojosen Clinic Asty45

    Hokkaido, 060-0004

  • Okamoto Naika Clinic_Hokkaido

    Hokkaido, 060-0042

  • Sapporo Tonyobyo Kojosen Clinic

    Hokkaido, 060-0807

  • Hokkaido Medical Center

    Hokkaido, 063-0005

  • Ito Hiroshi Naika Tonyobyonaika Clinic

    Hokkaido, 064-0824

  • Sapporo Yamahana Internal Medicine & Diabetes Clinic

    Hokkaido, 064-0917

  • Yoshimura Tonyobyo Clinic

    Hokkaido, 068-0021

  • Japanese Red Cross Asahikawa Hospital_Diabetes and Endocrinology

    Hokkaido, 070-8530

  • Kagetsu Clinic

    Hokkaido, 073-1105

  • Yamagata Naika Clinic

    Hokkaido, 078-8234

  • Honjo Naika Clinic

    Hokkaido, 080 0810

  • Owari Cardiovascular Diabetes Medicine Clinic

    Hosu-gun, Ishikawa, 927-0053

  • Shinkobe Okada Clinic

    Hyōgo, 650-0002

  • Kaisei Clinic

    Hyōgo, 651-2135

  • Hishikawa Naika Clinic

    Hyōgo, 656-0026

  • Konan Medical Center_Diabetes and Endocrinology

    Hyōgo, 658-0064

  • Sumiyoshigawa Byoin_Diabetes and Internal Medicine

    Hyōgo, 658-0084

  • Ashiya Municipal Hospital_Diabetes and Endocrinology

    Hyōgo, 659-8502

  • Yamasaki Family Clinic

    Hyōgo, 660-0861

  • Mitsuru Clinic

    Hyōgo, 660-0892

  • Taniguchi Medical Clinic

    Hyōgo, 661-0976

  • Azuma Diabetes Clinic

    Hyōgo, 662-0075

  • Nakayamadera Imai Clinic

    Hyōgo, 665-0861

  • Tsukazaki Memorial Hospital_Internal Medicine

    Hyōgo, 670-0053

  • Himeji St.Mary's Hospital_Gastroenterology - Hepatology

    Hyōgo, 670-0801

  • Fukatsu Naika Shinryojo

    Hyōgo, 672-8035

  • Yokota Medical Clinic

    Hyōgo, 673-0891

  • Akashi Medical Center

    Hyōgo, 674-0063

  • Tateya Clinic

    Hyōgo, 675-0156

  • Hirai Naika Clinic

    Hyōgo, 675-0314

  • Ono Hospital_Internal Medicine

    Hyōgo, 675-1316

  • Hyogo Prefectural Kakogawa Medical Center_Diabetes and Endocrinology

    Hyōgo, 675-8555

  • Obata Naika Tonyobyo Clinic

    Hyōgo, 678-0226

  • Ako City Hospital_Internal Medicine

    Hyōgo, 678-0232

  • Takabe Diabetes Clinic

    Hyogogoken, 670-0837

  • Tsuchiura Shinryo Kenshin Center

    Ibaraki, 300-0012

  • Tokyo Medical University Ibaraki Medical Center_Metabolism and Endocrinology

    Ibaraki, 300-0395

  • Iwaki Internal Medicine Clinic

    Ibaraki, 300-0504

  • Itabashi Diabetes and Dermatology Medical Clinic

    Ibaraki, 306-0232

  • Tomobe Central Clinic

    Ibaraki, 309-1703

  • Mito Kyodo General Hospital_Diabetes and Endocrinology

    Ibaraki, 310-0015

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Maeda Hospital_Internal Medicine

    Ibaraki, 314-0031

  • Ohgaku Clinic, Internal Medicine

    Imizu-shi, Toyama, Japan, 939 0363

  • Ohta Clinic, Internal Medicine

    Iruma-shi, Saitama, 358 0003

  • Isobe Tounyoubyou Naika Clinic

    Ishikawa, 920-0012

  • Kanazawa Medical University Hospital_Endocrinology and Metabolism

    Ishikawa, 920-0293

  • Iryo Houjin Hakuunkai Ryoya Komatsu Clinic,Internal medicine

    Izumisano, Osaka, Japan, 598 0048

  • Kagawa Prefectural Central Hospital_Diabetes and Endocrinology

    Kagawa, 760-8557

  • Akiyama Clinic

    Kagawa, 761-1701

  • Takahashi Seikeigeka Iin

    Kagawa, 762-0038

  • Osugi Neurosurgical Clinic

    Kagawa, 765-0052

  • Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine

    Kagawa, 765-0071

  • Tsuda Shinryojo

    Kagawa, 769-2401

  • Uenomachi Kajiya Clinic

    Kagoshima, 890-0073

  • Keiai Clinic

    Kagoshima, 891-0133

  • Fukuda Iin

    Kagoshima, 893-0014

  • Sonoda Clinic

    Kagoshima, 893-0022

  • Wakamatsu Kinen Byoin_Internal Medicine

    Kagoshima, 895-0052

  • Shimozono Clinic

    Kagoshima, 899-0214

  • Aira Tonyobyo Kojosen Naika Clinic

    Kagoshima, 899-5421

  • Tempozan Clinic of Internal Medicine

    Kagoshima-shi, Kagoshima, 890-0061

  • Takai Internal Medicine Clinic_Internal Medicine

    Kamakura-shi, Kanagawa, Kanagawa, Japan, 247 0056

  • Sun Marco Clinic

    Kanagawa, 211-0004

  • Nakahara Medical Clinic

    Kanagawa, 211-0041

  • Teikyo Univ.HP, Mizonokuchi_Fourth Internal Medicine

    Kanagawa, 213-8507

  • Kubota Clinic

    Kanagawa, 214-0014

  • Nishikawa Clinic

    Kanagawa, 222-0033

  • Tsunashima East Internal med & Diabetes

    Kanagawa, 223-0052

  • Yokohama City Minato Red Cross Hospital_Endocrinology

    Kanagawa, 231-8682

  • H.E.C Science Clinic

    Kanagawa, 235-0045

  • Kikuchi Naika Clinic_Kanagawa

    Kanagawa, 236-0033

  • Yokohama Minami Kyousai Hospital_Cardiology

    Kanagawa, 236-0037

  • Tagawa Naika Iin

    Kanagawa, 236-0058

  • Suzuki Diabetes Clinic

    Kanagawa, 243-0035

  • Yokohama Medical Center_Diabetes and Endocrinology

    Kanagawa, 245-8575

  • Shonan Takai Clinic_Internal Medicine

    Kanagawa, 247-0055

  • Odawara Municipal Hospital_Diabetes and Endocrinology

    Kanagawa, 250-8558

  • Sawa Internal Medicine and Diabetes Clinic

    Kanagawa, 251-0052

  • Internal Medicine Clinic Kobayashi

    Kanagawa, 252-0131

  • Higashirinkan Kaneshiro Diabetes Clinic

    Kanagawa, 252-0302

  • Chigasaki Municipal Hospital_Endocrinology and Metabolism

    Kanagawa, 253-0042

  • Hiratsuka Kyosai Hospital_Endocrinology and Metabolism

    Kanagawa, 254-8502

  • Kyourindo Clinic

    Kanagawa, 256-0816

  • Seichi Clinic

    Kanagawa, 259-1126

  • Tokai University Hospital_Cardiology

    Kanagawa, 259-1193

  • Asano Clinic

    Kawagoe-shi, Saitama, Japan, 350-0851

  • Matsuba Clinic_Internal Medicine

    Kawasaki-shi, Kanagawa, Japan, 212 0024

  • Hotaruno hakuyukai Medical Corporation of Japan

    Kisarazu-shi, Chiba, 292-0038

  • Kobe University Hospital_Diabetes and Endocrinology

    Kobe, Hyogo, 650-0017

  • Ueta Iin

    Kochi, 780-0843

  • Kikuchi Naika Clinic

    Kokuryō, 370-3573

  • Ringo no Hana Clinic

    Kokuryō, 372-0007

  • Morimura Clinic

    Kokuryō, 372-0812

  • Arai Shinryojo

    Kokuryō, 373-0852

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851

  • Koshigaya Laketown Clinic

    Koshigaya-shi,Saitama, 343 0828

  • Jinnouchi Hospital_Internal Medicine

    Kumamoto, Kumamoto, Japan, 862-0976

  • Tamana Central Hospital_Diabetes and Endocrinology

    Kumamoto, 865-0064

  • Minamata City General Hospital & Medical Center_Metabolism

    Kumamoto, 867-0041

  • Jujo Takeda Rehabilitation Hospital_Diabetes Internal Medicine

    Kyoto, 601-8325

  • Kyoto Goshominami Harashima Clinic

    Kyoto, 604-0884

  • Kamiuchi Naika Clinic

    Kyoto, 604-8416

  • Toyoda Medical Clinic

    Kyoto, 606-0025

  • Mata Clinic

    Kyoto, 607-8494

  • Oishi Naika Clinic

    Kyoto, 612-0875

  • Koide Iin

    Kyoto, 619-0224

  • Ayabe City Hospital_Endocrinology and Diabetes

    Kyoto, 623-0011

  • Mie Chuo Medical Center_Internal Medicine

    Mie, 514-1101

  • Mie University Hospital_Diabetes and Endocrinology

    Mie, 514-8507

  • MG Clinic

    Mie, 516-0035

  • Japanese Red Cross Ise Hospital_Diabetes and Metabolism

    Mie, 516-8512

  • Tokyo Saiseikai Central Hospitl, Internal Med

    Minatoku, Tokyo, Japan, 108 0073

  • Kanno Naika_Internal Medicine

    Mitaka-shi, Tokyo, 181-0013

  • Miura Central Clinic

    Miura-shi, Kanagawa, 238-0101

  • Shirai Healthcare Clinic Izumi-chuo

    Miyagi, 981-3133

  • Suzuki Kenichi Naika Clinic

    Miyagi, 982-0011

  • Yoshizumi Clinic Diabetes and Endocrinology

    Miyagi, 985-0863

  • Morita Iin

    Miyagi, 988-0084

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034

  • Koga General Hospital_Internal Medicine

    Miyazaki, 880-0041

  • Mitsukawa Naika Iin

    Miyazaki, 880-0806

  • Nichinan Chubu Hospital_Internal Medicine

    Miyazaki, 889-3141

  • Sumi Byoin_Internal Medicine

    Miyazaki, 889-4505

  • Ato internal medicine clinic, internal medicine

    Muroran-shi, Hokkaido, 050-0073

  • Asama General Hospital_Diabetology

    Nagano, 385-8558

  • Houden Clinic

    Nagano, 386-0004

  • Shinshu Ueda Medical Center_Diabetes and Endocrinology

    Nagano, 386-8610

  • Iida Municipal Hospital_Diabetes and Metabolism

    Nagano, 395-8502

  • Kenwakai Hospital_Dialysis center

    Nagano, 395-8522

  • Ina Central Hospital_Internal Medicine

    Nagano, 396-0033

  • Saiseikai Nagasaki Hospital_Endocrinology and Diabetes

    Nagasaki, 850-0003

  • Yuzu Clinic

    Nagasaki, 850-0831

  • Onitsuka Naika Shokakika

    Nagasaki, 851-0405

  • Miyazaki Naika

    Nagasaki, 852-8042

  • Tetsuo Naika Iin

    Nagasaki, 852-8107

  • Japanese Red Cross Nagasaki Genbaku Hospital_Metabolism and Endocrinology

    Nagasaki, 852-8511

  • Nakamura Iin

    Nagasaki, 856-0831

  • Sasebo City General Hospital_Diabetes and Endocrinology

    Nagasaki, 857-8511

  • Harada Tonyobyo Jin Naika Clinic

    Nara, 631-0003

  • Hikari Clinic

    Nara, 631-0036

  • Imamura Tonyobyo Naika Tsuda Geka Shinryojo

    Nara, 631-0813

  • Furuya Clinic

    Nara, 631-0842

  • Okamoto Internal Medicine and Pediatrics Clinic

    Nara, 633-0064

  • Mashitani Naika Clinic

    Nara, 635-0015

  • Ikenaka Naika Clinic

    Nara, 635-0825

  • Seiwadai Clinic

    Nara, 636-0081

  • Enomoto Clinic

    Nara, 639-2251

  • Minagawa Clinic Internal Medicine

    Niigata, 942-0052

  • Takahashi Iin

    Niigata, 943-0893

  • Uchiyama Iin

    Niigata, 949-3443

  • Niigata Prefectural Sakamachi Hospital_Internal Medicine

    Niigata, 959-3193

  • Saiseikai Niigata Hospital_Metabolism and Endocrinology

    Niigata-shi, Niigata, 950-1104

  • Hyogo College Hospital_Diabetes and Endocrinology

    Nishinomiya-shi, Hyogo, 663-8501

  • Kaneko Gastroenterologist Internal Medicine

    Numakunai, 020-0403

  • Abies Kanno Clinic

    Numakunai, 021-0002

  • Kitakamiekimae Naika Clinic

    Numakunai, 024-0061

  • Iwate Medical University Hospital_Diabetes and Metabolism

    Numakunai, 028-3695

  • Abe Diabetes Clinic_Internal Medicine

    Ōita, Oita, Japan, 870 0039

  • Oita Prefectural Hospital_Endocrinology and Metabolism

    Ōita, 870 8511

  • Kayashima Clinic

    Ōita, 870-0935

  • Cosmos Byoin_Internal Medicine

    Ōita, 875-0051

  • Takada Chuo Byoin_Diabetes Internal Medicine

    Ōita, 879-0627

  • Okamoto Clinic for Diabetes and Endocrinology

    Ōita, 879-7301

  • Okayama University Hospital_Neph. and Diabetes, Metabolism

    Okayama, 700-8558

  • Obata Medical Clinic

    Okayama, 708-0806

  • Shigei Byoin_Internal Medicine

    Okayama, 710-0051

  • Kojima Marine Clinic

    Okayama, 711-0923

  • Kasaoka Daiichi Hospital_Internal Medicine

    Okayama, 714-0043

  • Okayama Medical Center_Cardiology

    Okayama-shi, Okayama, 701-1192

  • Tokuyama Clinic

    Okinawa, 901-2131

  • Shuri Jokamachi Clinic

    Okinawa, 902-0062

  • Chibana Clinic

    Okinawa, 904-2143

  • Sunagawa Medical Clinic

    Okinawa, 904-2244

  • Taiyono Clinic

    Okinawa, 905-0018

  • Tanaka Naika

    Osaka, 530-0004

  • Nishimura Clinic

    Osaka, 530-0012

  • Manabe Iin

    Osaka, 533-0001

  • Osaka City General Hospital

    Osaka, 534-0021

  • Yasuda Diabetes Clinic

    Osaka, 536-0002

  • Osaka National Hospital_Diabetes Internal Medicine

    Osaka, 540-0006

  • Kosugi Medical Clinic

    Osaka, 543-0014

  • Osaka Police Hospital_Diabetes and Endocrinology

    Osaka, 543-0035

  • Osaka City University Hospital_Metabolism and Endocrinology

    Osaka, 545-8586

  • Matsumoto Clinic

    Osaka, 553-0002

  • Kansai Electric Power Hospital_Center for Diabetes

    Osaka, 553-0003

  • Ichiyoshi Iin

    Osaka, 558-0013

  • Osaka General Medical Center_Cardiology

    Osaka, 558-8558

  • Jo's Medical Clinic

    Osaka, 561-0833

  • Minamitani Clinic

    Osaka, 561-0884

  • Nakanishi Clinic

    Osaka, 563-0033

  • Mori Clinic

    Osaka, 565-0842

  • Maeda Clinic

    Osaka, 565-0874

  • Masuda Clinic

    Osaka, 567-0886

  • Sawaki Internal Medicine And Diabetes Clinic

    Osaka, 569-0804

  • Hokusetsu General Hospital_Diabetes and Endocrinology

    Osaka, 569-8585

  • Matsushita Memorial Hospital_Diabetes and Endocrinology

    Osaka, 570-8540

  • Tesseikai Noshinkeigeka Byoin_Cardiology

    Osaka, 575-8511

  • Iwasaki Naika Clinic

    Osaka, 577-0802

  • Ogawa Clinic

    Osaka, 581-0869

  • Matsuda Gastroenterology and Diabetes Clinic

    Osaka, 591-8006

  • Jonin Ueda Clinic

    Osaka, 598-0011

Other trials in Japan

About this study

Official title: 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®.

Being tested
semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutideDrug

    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.

Study groups in NCT04469855
Study groupRoleWhat they receive
Ozempic®Japanese people with type 2 diabetes being treated in normal clinical practice conditions
Receives: Drug: semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events (AEs)

    Count

    Measured: From baseline (day 0) to end of study (month 36)

Secondary outcomes (11)

  1. Number of serious adverse reactions (SARs)

    Count

    Measured: From baseline (day 0) to end of study (month 36)

  2. Number of adverse reactions (ARs)

    Count

    Measured: From baseline (day 0) to end of study (month 36)

  3. Number of serious adverse events (SAEs)

    Count

    Measured: From baseline (day 0) to end of study (month 36)

  4. Change in glycosylated haemoglobin A1c (HbA1c)

    Percent

    Measured: From baseline (day 0) to end of study (month 36)

  5. Change in fasting plasma glucose (FPG)

    mg/dL

    Measured: From baseline (day 0) to end of study (month 36)

  6. Change in body weight

    kg

    Measured: From baseline (day 0) to end of study (month 36)

  7. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score

    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)

    Measured: From baseline (day 0) to visit 5 (month 12)

  8. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities

    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)

    Measured: From baseline (day 0) to visit 5 (month 12)

  9. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment

    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)

    Measured: From baseline (day 0) to visit 5 (month 12)

  10. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia

    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)

    Measured: From baseline (day 0) to visit 5 (month 12)

  11. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment

    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)

    Measured: From baseline (day 0) to visit 5 (month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start27 Jul 2020
  3. Primary completion12 May 2025
  4. Study completion12 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469855
Sponsor's protocol ID
NN9535-4347
Other IDs
U1111-1187-9072
Status last verified
May 2026
First submitted
10 Jul 2020
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 414 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 414 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (AEs) (time frame: From baseline (day 0) to end of study (month 36)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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