Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04469855
Collaborator
(none)
3,000
414
60.1
7.2
0.1
Study Details
Study Description
Brief 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. 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®.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date
:
Jul 27, 2020
Anticipated Primary Completion Date
:
Jul 31, 2025
Anticipated Study Completion Date
:
Jul 31, 2025
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Number of adverse events (AEs) [From baseline (day 0) to end of study (month 36)]
Count
Secondary Outcome Measures
- Number of serious adverse reactions (SARs) [From baseline (day 0) to end of study (month 36)]
Count
- Number of adverse reactions (ARs) [From baseline (day 0) to end of study (month 36)]
Count
- Number of serious adverse events (SAEs) [From baseline (day 0) to end of study (month 36)]
Count
- Change in glycosylated haemoglobin A1c (HbA1c) [From baseline (day 0) to end of study (month 36)]
Percent
- Change in fasting plasma glucose (FPG) [From baseline (day 0) to end of study (month 36)]
mg/dL
- Change in body weight [From baseline (day 0) to end of study (month 36)]
kg
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score [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)
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities [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)
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment [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)
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia [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)
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment [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)
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Aichi | Japan | 441-8087 | |
| 2 | Novo Nordisk Investigational Site | Aichi | Japan | 443-0022 | |
| 3 | Novo Nordisk Investigational Site | Aichi | Japan | 446-0044 | |
| 4 | Novo Nordisk Investigational Site | Aichi | Japan | 448-0852 | |
| 5 | Novo Nordisk Investigational Site | Aichi | Japan | 450-0002 | |
| 6 | Novo Nordisk Investigational Site | Aichi | Japan | 451-8511 | |
| 7 | Novo Nordisk Investigational Site | Aichi | Japan | 455-0815 | |
| 8 | Novo Nordisk Investigational Site | Aichi | Japan | 455-0857 | |
| 9 | Novo Nordisk Investigational Site | Aichi | Japan | 458-0011 | |
| 10 | Novo Nordisk Investigational Site | Aichi | Japan | 462-0037 | |
| 11 | Novo Nordisk Investigational Site | Aichi | Japan | 462-0047 | |
| 12 | Novo Nordisk Investigational Site | Aichi | Japan | 468-0009 | |
| 13 | Novo Nordisk Investigational Site | Aichi | Japan | 470-0345 | |
| 14 | Novo Nordisk Investigational Site | Aichi | Japan | 472-0014 | |
| 15 | Novo Nordisk Investigational Site | Aichi | Japan | 476-0011 | |
| 16 | Novo Nordisk Investigational Site | Aichi | Japan | 484-0066 | |
| 17 | Novo Nordisk Investigational Site | Aichi | Japan | 485-0044 | |
| 18 | Novo Nordisk Investigational Site | Aichi | Japan | 489-8642 | |
| 19 | Novo Nordisk Investigational Site | Akita | Japan | 016-0014 | |
| 20 | Novo Nordisk Investigational Site | Akita | Japan | 017-8550 | |
| 21 | Novo Nordisk Investigational Site | Akita | Japan | 018-4301 | |
| 22 | Novo Nordisk Investigational Site | Aomori | Japan | 030-0823 | |
| 23 | Novo Nordisk Investigational Site | Aomori | Japan | 038-0011 | |
| 24 | Novo Nordisk Investigational Site | Arakawa-ku, Tokyo | Japan | 116-0012 | |
| 25 | Novo Nordisk Investigational Site | Asahikawa-shi, Hokkaido | Japan | 078-8211 | |
| 26 | Novo Nordisk Investigational Site | Chiba-shi, Chiba | Japan | 260-0804 | |
| 27 | Novo Nordisk Investigational Site | Chiba | Japan | 264-0017 | |
| 28 | Novo Nordisk Investigational Site | Chiba | Japan | 271-0044 | |
| 29 | Novo Nordisk Investigational Site | Chiba | Japan | 272-0033 | |
| 30 | Novo Nordisk Investigational Site | Chiba | Japan | 274-0063 | |
| 31 | Novo Nordisk Investigational Site | Chiba | Japan | 274-0805 | |
| 32 | Novo Nordisk Investigational Site | Chiba | Japan | 277-0084 | |
| 33 | Novo Nordisk Investigational Site | Chiba | Japan | 277-8567 | |
| 34 | Novo Nordisk Investigational Site | Chiba | Japan | 279-0001 | |
| 35 | Novo Nordisk Investigational Site | Chiba | Japan | 283-0811 | |
| 36 | Novo Nordisk Investigational Site | Chiba | Japan | 286-0221 | |
| 37 | Novo Nordisk Investigational Site | Chiba | Japan | 290-0512 | |
| 38 | Novo Nordisk Investigational Site | Chiba | Japan | 292-0822 | |
| 39 | Novo Nordisk Investigational Site | Chiba | Japan | 295-0021 | |
| 40 | Novo Nordisk Investigational Site | Chiba | Japan | 299-1144 | |
| 41 | Novo Nordisk Investigational Site | Chichibu-city | Japan | 368-0004 | |
| 42 | Novo Nordisk Investigational Site | Chitose, Hokkaido | Japan | 066-0032 | |
| 43 | Novo Nordisk Investigational Site | Ehime | Japan | 790-0026 | |
| 44 | Novo Nordisk Investigational Site | Ehime | Japan | 790-0034 | |
| 45 | Novo Nordisk Investigational Site | Ehime | Japan | 791-0281 | |
| 46 | Novo Nordisk Investigational Site | Ehime | Japan | 791-8001 | |
| 47 | Novo Nordisk Investigational Site | Ehime | Japan | 791-8016 | |
| 48 | Novo Nordisk Investigational Site | Ehime | Japan | 791-8026 | |
| 49 | Novo Nordisk Investigational Site | Ehime | Japan | 792-0042 | |
| 50 | Novo Nordisk Investigational Site | Ehime | Japan | 792-8586 | |
| 51 | Novo Nordisk Investigational Site | Ehime | Japan | 794-0054 | |
| 52 | Novo Nordisk Investigational Site | Ehime | Japan | 798-8510 | |
| 53 | Novo Nordisk Investigational Site | Ehime | Japan | 799-0193 | |
| 54 | Novo Nordisk Investigational Site | Fukui-shi, Fukui | Japan | 918-8503 | |
| 55 | Novo Nordisk Investigational Site | Fukui | Japan | 910-0003 | |
| 56 | Novo Nordisk Investigational Site | Fukuoka-shi, Fukuoka | Japan | 819-0006 | |
| 57 | Novo Nordisk Investigational Site | Fukuoka | Japan | 800-0296 | |
| 58 | Novo Nordisk Investigational Site | Fukuoka | Japan | 803-0845 | |
| 59 | Novo Nordisk Investigational Site | Fukuoka | Japan | 804-0062 | |
| 60 | Novo Nordisk Investigational Site | Fukuoka | Japan | 805-0031 | |
| 61 | Novo Nordisk Investigational Site | Fukuoka | Japan | 807-1112 | |
| 62 | Novo Nordisk Investigational Site | Fukuoka | Japan | 8100001 | |
| 63 | Novo Nordisk Investigational Site | Fukuoka | Japan | 811-2122 | |
| 64 | Novo Nordisk Investigational Site | Fukuoka | Japan | 811-3217 | |
| 65 | Novo Nordisk Investigational Site | Fukuoka | Japan | 812-0053 | |
| 66 | Novo Nordisk Investigational Site | Fukuoka | Japan | 815-0033 | |
| 67 | Novo Nordisk Investigational Site | Fukuoka | Japan | 815-0071 | |
| 68 | Novo Nordisk Investigational Site | Fukuoka | Japan | 818-0072 | |
| 69 | Novo Nordisk Investigational Site | Fukuoka | Japan | 819-1102 | |
| 70 | Novo Nordisk Investigational Site | Fukuoka | Japan | 820-0076 | |
| 71 | Novo Nordisk Investigational Site | Fukuoka | Japan | 825-0002 | |
| 72 | Novo Nordisk Investigational Site | Fukuoka | Japan | 832-0032 | |
| 73 | Novo Nordisk Investigational Site | Fukuoka | Japan | 833-0041 | |
| 74 | Novo Nordisk Investigational Site | Fukuoka | Japan | 834-0115 | |
| 75 | Novo Nordisk Investigational Site | Fukushima-shi, Fukushima | Japan | 960-8001 | |
| 76 | Novo Nordisk Investigational Site | Fukushima | Japan | 961-8031 | |
| 77 | Novo Nordisk Investigational Site | Fukushima | Japan | 963-8851 | |
| 78 | Novo Nordisk Investigational Site | Fukushima | Japan | 965-0853 | |
| 79 | Novo Nordisk Investigational Site | Fukushima | Japan | 973-8402 | |
| 80 | Novo Nordisk Investigational Site | Gifu-shi, Gifu | Japan | 501-1194 | |
| 81 | Novo Nordisk Investigational Site | Gifu | Japan | 500-8381 | |
| 82 | Novo Nordisk Investigational Site | Gifu | Japan | 501-6003 | |
| 83 | Novo Nordisk Investigational Site | Gifu | Japan | 501-6018 | |
| 84 | Novo Nordisk Investigational Site | Gifu | Japan | 501-6062 | |
| 85 | Novo Nordisk Investigational Site | Gifu | Japan | 504-0829 | |
| 86 | Novo Nordisk Investigational Site | Gifu | Japan | 506-0053 | |
| 87 | Novo Nordisk Investigational Site | Gumma | Japan | 370-3573 | |
| 88 | Novo Nordisk Investigational Site | Gumma | Japan | 372-0007 | |
| 89 | Novo Nordisk Investigational Site | Gumma | Japan | 372-0812 | |
| 90 | Novo Nordisk Investigational Site | Gumma | Japan | 373-0852 | |
| 91 | Novo Nordisk Investigational Site | Gunma | Japan | 370-0069 | |
| 92 | Novo Nordisk Investigational Site | Gunma | Japan | 373-0036 | |
| 93 | Novo Nordisk Investigational Site | Gunma | Japan | 374-0052 | |
| 94 | Novo Nordisk Investigational Site | Higashiosaka-shi, Osaka | Japan | 577 0803 | |
| 95 | Novo Nordisk Investigational Site | Hiroshima | Japan | 720-1131 | |
| 96 | Novo Nordisk Investigational Site | Hiroshima | Japan | 722-0002 | |
| 97 | Novo Nordisk Investigational Site | Hiroshima | Japan | 722-0014 | |
| 98 | Novo Nordisk Investigational Site | Hiroshima | Japan | 730-8619 | |
| 99 | Novo Nordisk Investigational Site | Hiroshima | Japan | 733-0033 | |
| 100 | Novo Nordisk Investigational Site | Hiroshima | Japan | 739-0041 | |
| 101 | Novo Nordisk Investigational Site | Hokkaido | Japan | 041-0821 | |
| 102 | Novo Nordisk Investigational Site | Hokkaido | Japan | 047-0021 | |
| 103 | Novo Nordisk Investigational Site | Hokkaido | Japan | 053-0042 | |
| 104 | Novo Nordisk Investigational Site | Hokkaido | Japan | 060-0004 | |
| 105 | Novo Nordisk Investigational Site | Hokkaido | Japan | 060-0042 | |
| 106 | Novo Nordisk Investigational Site | Hokkaido | Japan | 060-0807 | |
| 107 | Novo Nordisk Investigational Site | Hokkaido | Japan | 063-0005 | |
| 108 | Novo Nordisk Investigational Site | Hokkaido | Japan | 064-0824 | |
| 109 | Novo Nordisk Investigational Site | Hokkaido | Japan | 064-0917 | |
| 110 | Novo Nordisk Investigational Site | Hokkaido | Japan | 068-0021 | |
| 111 | Novo Nordisk Investigational Site | Hokkaido | Japan | 070-8530 | |
| 112 | Novo Nordisk Investigational Site | Hokkaido | Japan | 073-1105 | |
| 113 | Novo Nordisk Investigational Site | Hokkaido | Japan | 078-8234 | |
| 114 | Novo Nordisk Investigational Site | Hokkaido | Japan | 080 0810 | |
| 115 | Novo Nordisk Investigational Site | Hosu-gun, Ishikawa | Japan | 927-0053 | |
| 116 | Novo Nordisk Investigational Site | Hyogogoken | Japan | 670-0837 | |
| 117 | Novo Nordisk Investigational Site | Hyogo | Japan | 650-0002 | |
| 118 | Novo Nordisk Investigational Site | Hyogo | Japan | 651-2135 | |
| 119 | Novo Nordisk Investigational Site | Hyogo | Japan | 656-0026 | |
| 120 | Novo Nordisk Investigational Site | Hyogo | Japan | 658-0064 | |
| 121 | Novo Nordisk Investigational Site | Hyogo | Japan | 658-0084 | |
| 122 | Novo Nordisk Investigational Site | Hyogo | Japan | 659-8502 | |
| 123 | Novo Nordisk Investigational Site | Hyogo | Japan | 660-0861 | |
| 124 | Novo Nordisk Investigational Site | Hyogo | Japan | 660-0892 | |
| 125 | Novo Nordisk Investigational Site | Hyogo | Japan | 661-0976 | |
| 126 | Novo Nordisk Investigational Site | Hyogo | Japan | 662-0075 | |
| 127 | Novo Nordisk Investigational Site | Hyogo | Japan | 665-0861 | |
| 128 | Novo Nordisk Investigational Site | Hyogo | Japan | 670-0053 | |
| 129 | Novo Nordisk Investigational Site | Hyogo | Japan | 670-0801 | |
| 130 | Novo Nordisk Investigational Site | Hyogo | Japan | 672-8035 | |
| 131 | Novo Nordisk Investigational Site | Hyogo | Japan | 673-0891 | |
| 132 | Novo Nordisk Investigational Site | Hyogo | Japan | 674-0063 | |
| 133 | Novo Nordisk Investigational Site | Hyogo | Japan | 675-0156 | |
| 134 | Novo Nordisk Investigational Site | Hyogo | Japan | 675-0314 | |
| 135 | Novo Nordisk Investigational Site | Hyogo | Japan | 675-1316 | |
| 136 | Novo Nordisk Investigational Site | Hyogo | Japan | 675-8555 | |
| 137 | Novo Nordisk Investigational Site | Hyogo | Japan | 678-0226 | |
| 138 | Novo Nordisk Investigational Site | Hyogo | Japan | 678-0232 | |
| 139 | Novo Nordisk Investigational Site | Ibaraki | Japan | 300-0012 | |
| 140 | Novo Nordisk Investigational Site | Ibaraki | Japan | 300-0395 | |
| 141 | Novo Nordisk Investigational Site | Ibaraki | Japan | 300-0504 | |
| 142 | Novo Nordisk Investigational Site | Ibaraki | Japan | 306-0232 | |
| 143 | Novo Nordisk Investigational Site | Ibaraki | Japan | 309-1703 | |
| 144 | Novo Nordisk Investigational Site | Ibaraki | Japan | 310-0015 | |
| 145 | Novo Nordisk Investigational Site | Ibaraki | Japan | 311-0113 | |
| 146 | Novo Nordisk Investigational Site | Ibaraki | Japan | 314-0031 | |
| 147 | Novo Nordisk Investigational Site | Imizu-shi | Japan | 939 0363 | |
| 148 | Novo Nordisk Investigational Site | Iruma-shi, Saitama | Japan | 358 0003 | |
| 149 | Novo Nordisk Investigational Site | Ishikawa | Japan | 920-0012 | |
| 150 | Novo Nordisk Investigational Site | Ishikawa | Japan | 920-0293 | |
| 151 | Novo Nordisk Investigational Site | Iwate | Japan | 020-0403 | |
| 152 | Novo Nordisk Investigational Site | Iwate | Japan | 021-0002 | |
| 153 | Novo Nordisk Investigational Site | Iwate | Japan | 024-0061 | |
| 154 | Novo Nordisk Investigational Site | Iwate | Japan | 028-3695 | |
| 155 | Novo Nordisk Investigational Site | Izumisano-shi | Japan | 598 0048 | |
| 156 | Novo Nordisk Investigational Site | Kagawa | Japan | 760-8557 | |
| 157 | Novo Nordisk Investigational Site | Kagawa | Japan | 761-1701 | |
| 158 | Novo Nordisk Investigational Site | Kagawa | Japan | 762-0038 | |
| 159 | Novo Nordisk Investigational Site | Kagawa | Japan | 765-0052 | |
| 160 | Novo Nordisk Investigational Site | Kagawa | Japan | 765-0071 | |
| 161 | Novo Nordisk Investigational Site | Kagawa | Japan | 769-2401 | |
| 162 | Novo Nordisk Investigational Site | Kagoshima-shi, Kagoshima | Japan | 890-0061 | |
| 163 | Novo Nordisk Investigational Site | Kagoshima | Japan | 890-0073 | |
| 164 | Novo Nordisk Investigational Site | Kagoshima | Japan | 891-0133 | |
| 165 | Novo Nordisk Investigational Site | Kagoshima | Japan | 893-0014 | |
| 166 | Novo Nordisk Investigational Site | Kagoshima | Japan | 893-0022 | |
| 167 | Novo Nordisk Investigational Site | Kagoshima | Japan | 895-0052 | |
| 168 | Novo Nordisk Investigational Site | Kagoshima | Japan | 899-0214 | |
| 169 | Novo Nordisk Investigational Site | Kagoshima | Japan | 899-5421 | |
| 170 | Novo Nordisk Investigational Site | Kamakura-shi | Japan | 247 0056 | |
| 171 | Novo Nordisk Investigational Site | Kanagawa | Japan | 211-0004 | |
| 172 | Novo Nordisk Investigational Site | Kanagawa | Japan | 211-0041 | |
| 173 | Novo Nordisk Investigational Site | Kanagawa | Japan | 213-8507 | |
| 174 | Novo Nordisk Investigational Site | Kanagawa | Japan | 214-0014 | |
| 175 | Novo Nordisk Investigational Site | Kanagawa | Japan | 222-0033 | |
| 176 | Novo Nordisk Investigational Site | Kanagawa | Japan | 223-0052 | |
| 177 | Novo Nordisk Investigational Site | Kanagawa | Japan | 231-8682 | |
| 178 | Novo Nordisk Investigational Site | Kanagawa | Japan | 235-0045 | |
| 179 | Novo Nordisk Investigational Site | Kanagawa | Japan | 236-0033 | |
| 180 | Novo Nordisk Investigational Site | Kanagawa | Japan | 236-0037 | |
| 181 | Novo Nordisk Investigational Site | Kanagawa | Japan | 236-0058 | |
| 182 | Novo Nordisk Investigational Site | Kanagawa | Japan | 243-0035 | |
| 183 | Novo Nordisk Investigational Site | Kanagawa | Japan | 245-8575 | |
| 184 | Novo Nordisk Investigational Site | Kanagawa | Japan | 247-0055 | |
| 185 | Novo Nordisk Investigational Site | Kanagawa | Japan | 250-8558 | |
| 186 | Novo Nordisk Investigational Site | Kanagawa | Japan | 251-0052 | |
| 187 | Novo Nordisk Investigational Site | Kanagawa | Japan | 252-0131 | |
| 188 | Novo Nordisk Investigational Site | Kanagawa | Japan | 252-0302 | |
| 189 | Novo Nordisk Investigational Site | Kanagawa | Japan | 253-0042 | |
| 190 | Novo Nordisk Investigational Site | Kanagawa | Japan | 254-8502 | |
| 191 | Novo Nordisk Investigational Site | Kanagawa | Japan | 256-0816 | |
| 192 | Novo Nordisk Investigational Site | Kanagawa | Japan | 259-1126 | |
| 193 | Novo Nordisk Investigational Site | Kanagawa | Japan | 259-1193 | |
| 194 | Novo Nordisk Investigational Site | Kawagoe-shi, Saitama | Japan | 350-0851 | |
| 195 | Novo Nordisk Investigational Site | Kawasaki-shi | Japan | 212 0024 | |
| 196 | Novo Nordisk Investigational Site | Kisarazu-shi, Chiba | Japan | 292-0038 | |
| 197 | Novo Nordisk Investigational Site | Kobe, Hyogo | Japan | 650-0017 | |
| 198 | Novo Nordisk Investigational Site | Kochi | Japan | 780-0843 | |
| 199 | Novo Nordisk Investigational Site | Koshigaya-shi,Saitama | Japan | 343 0828 | |
| 200 | Novo Nordisk Investigational Site | Kumamoto | Japan | 862-0976 | |
| 201 | Novo Nordisk Investigational Site | Kumamoto | Japan | 865-0064 | |
| 202 | Novo Nordisk Investigational Site | Kumamoto | Japan | 867-0041 | |
| 203 | Novo Nordisk Investigational Site | Kyoto | Japan | 601-8325 | |
| 204 | Novo Nordisk Investigational Site | Kyoto | Japan | 604-0884 | |
| 205 | Novo Nordisk Investigational Site | Kyoto | Japan | 604-8416 | |
| 206 | Novo Nordisk Investigational Site | Kyoto | Japan | 606-0025 | |
| 207 | Novo Nordisk Investigational Site | Kyoto | Japan | 607-8494 | |
| 208 | Novo Nordisk Investigational Site | Kyoto | Japan | 612-0875 | |
| 209 | Novo Nordisk Investigational Site | Kyoto | Japan | 619-0224 | |
| 210 | Novo Nordisk Investigational Site | Kyoto | Japan | 623-0011 | |
| 211 | Novo Nordisk Investigational Site | Mie | Japan | 514-1101 | |
| 212 | Novo Nordisk Investigational Site | Mie | Japan | 514-8507 | |
| 213 | Novo Nordisk Investigational Site | Mie | Japan | 516-0035 | |
| 214 | Novo Nordisk Investigational Site | Mie | Japan | 516-8512 | |
| 215 | Novo Nordisk Investigational Site | Minato-ku | Japan | 108 0073 | |
| 216 | Novo Nordisk Investigational Site | Mitaka-shi, Tokyo | Japan | 181-0013 | |
| 217 | Novo Nordisk Investigational Site | Miura-shi, Kanagawa | Japan | 238-0101 | |
| 218 | Novo Nordisk Investigational Site | Miyagi | Japan | 981-3133 | |
| 219 | Novo Nordisk Investigational Site | Miyagi | Japan | 982-0011 | |
| 220 | Novo Nordisk Investigational Site | Miyagi | Japan | 985-0863 | |
| 221 | Novo Nordisk Investigational Site | Miyagi | Japan | 988-0084 | |
| 222 | Novo Nordisk Investigational Site | Miyazaki | Japan | 880-0034 | |
| 223 | Novo Nordisk Investigational Site | Miyazaki | Japan | 880-0041 | |
| 224 | Novo Nordisk Investigational Site | Miyazaki | Japan | 880-0806 | |
| 225 | Novo Nordisk Investigational Site | Miyazaki | Japan | 889-3141 | |
| 226 | Novo Nordisk Investigational Site | Miyazaki | Japan | 889-4505 | |
| 227 | Novo Nordisk Investigational Site | Muroran-shi, Hokkaido | Japan | 050-0073 | |
| 228 | Novo Nordisk Investigational Site | Nagano | Japan | 385-8558 | |
| 229 | Novo Nordisk Investigational Site | Nagano | Japan | 386-0004 | |
| 230 | Novo Nordisk Investigational Site | Nagano | Japan | 386-8610 | |
| 231 | Novo Nordisk Investigational Site | Nagano | Japan | 395-8502 | |
| 232 | Novo Nordisk Investigational Site | Nagano | Japan | 395-8522 | |
| 233 | Novo Nordisk Investigational Site | Nagano | Japan | 396-0033 | |
| 234 | Novo Nordisk Investigational Site | Nagasaki | Japan | 850-0003 | |
| 235 | Novo Nordisk Investigational Site | Nagasaki | Japan | 850-0831 | |
| 236 | Novo Nordisk Investigational Site | Nagasaki | Japan | 851-0405 | |
| 237 | Novo Nordisk Investigational Site | Nagasaki | Japan | 852-8042 | |
| 238 | Novo Nordisk Investigational Site | Nagasaki | Japan | 852-8107 | |
| 239 | Novo Nordisk Investigational Site | Nagasaki | Japan | 852-8511 | |
| 240 | Novo Nordisk Investigational Site | Nagasaki | Japan | 856-0831 | |
| 241 | Novo Nordisk Investigational Site | Nagasaki | Japan | 857-8511 | |
| 242 | Novo Nordisk Investigational Site | Nara | Japan | 631-0003 | |
| 243 | Novo Nordisk Investigational Site | Nara | Japan | 631-0036 | |
| 244 | Novo Nordisk Investigational Site | Nara | Japan | 631-0813 | |
| 245 | Novo Nordisk Investigational Site | Nara | Japan | 631-0842 | |
| 246 | Novo Nordisk Investigational Site | Nara | Japan | 633-0064 | |
| 247 | Novo Nordisk Investigational Site | Nara | Japan | 635-0015 | |
| 248 | Novo Nordisk Investigational Site | Nara | Japan | 635-0825 | |
| 249 | Novo Nordisk Investigational Site | Nara | Japan | 636-0081 | |
| 250 | Novo Nordisk Investigational Site | Nara | Japan | 639-2251 | |
| 251 | Novo Nordisk Investigational Site | Niigata-shi, Niigata | Japan | 950-1104 | |
| 252 | Novo Nordisk Investigational Site | Niigata | Japan | 942-0052 | |
| 253 | Novo Nordisk Investigational Site | Niigata | Japan | 943-0893 | |
| 254 | Novo Nordisk Investigational Site | Niigata | Japan | 949-3443 | |
| 255 | Novo Nordisk Investigational Site | Niigata | Japan | 959-3193 | |
| 256 | Novo Nordisk Investigational Site | Nishinomiya-shi, Hyogo | Japan | 663-8501 | |
| 257 | Novo Nordisk Investigational Site | Oita-shi | Japan | 870 0039 | |
| 258 | Novo Nordisk Investigational Site | Oita | Japan | 870 8511 | |
| 259 | Novo Nordisk Investigational Site | Oita | Japan | 870-0935 | |
| 260 | Novo Nordisk Investigational Site | Oita | Japan | 875-0051 | |
| 261 | Novo Nordisk Investigational Site | Oita | Japan | 879-0627 | |
| 262 | Novo Nordisk Investigational Site | Oita | Japan | 879-7301 | |
| 263 | Novo Nordisk Investigational Site | Okayama-shi, Okayama | Japan | 701-1192 | |
| 264 | Novo Nordisk Investigational Site | Okayama | Japan | 700-8558 | |
| 265 | Novo Nordisk Investigational Site | Okayama | Japan | 708-0806 | |
| 266 | Novo Nordisk Investigational Site | Okayama | Japan | 710-0051 | |
| 267 | Novo Nordisk Investigational Site | Okayama | Japan | 711-0923 | |
| 268 | Novo Nordisk Investigational Site | Okayama | Japan | 714-0043 | |
| 269 | Novo Nordisk Investigational Site | Okinawa | Japan | 901-2131 | |
| 270 | Novo Nordisk Investigational Site | Okinawa | Japan | 902-0062 | |
| 271 | Novo Nordisk Investigational Site | Okinawa | Japan | 904-2143 | |
| 272 | Novo Nordisk Investigational Site | Okinawa | Japan | 904-2244 | |
| 273 | Novo Nordisk Investigational Site | Okinawa | Japan | 905-0018 | |
| 274 | Novo Nordisk Investigational Site | Osaka-shi, Osaka | Japan | 532 0003 | |
| 275 | Novo Nordisk Investigational Site | Osaka-shi, Osaka | Japan | 533-0024 | |
| 276 | Novo Nordisk Investigational Site | Osaka-shi, Osaka | Japan | 536-0001 | |
| 277 | Novo Nordisk Investigational Site | Osaka | Japan | 530-0004 | |
| 278 | Novo Nordisk Investigational Site | Osaka | Japan | 530-0012 | |
| 279 | Novo Nordisk Investigational Site | Osaka | Japan | 533-0001 | |
| 280 | Novo Nordisk Investigational Site | Osaka | Japan | 534-0021 | |
| 281 | Novo Nordisk Investigational Site | Osaka | Japan | 536-0002 | |
| 282 | Novo Nordisk Investigational Site | Osaka | Japan | 540-0006 | |
| 283 | Novo Nordisk Investigational Site | Osaka | Japan | 543-0014 | |
| 284 | Novo Nordisk Investigational Site | Osaka | Japan | 543-0035 | |
| 285 | Novo Nordisk Investigational Site | Osaka | Japan | 545-8586 | |
| 286 | Novo Nordisk Investigational Site | Osaka | Japan | 553-0002 | |
| 287 | Novo Nordisk Investigational Site | Osaka | Japan | 553-0003 | |
| 288 | Novo Nordisk Investigational Site | Osaka | Japan | 558-0013 | |
| 289 | Novo Nordisk Investigational Site | Osaka | Japan | 558-8558 | |
| 290 | Novo Nordisk Investigational Site | Osaka | Japan | 561-0833 | |
| 291 | Novo Nordisk Investigational Site | Osaka | Japan | 561-0884 | |
| 292 | Novo Nordisk Investigational Site | Osaka | Japan | 563-0033 | |
| 293 | Novo Nordisk Investigational Site | Osaka | Japan | 565-0842 | |
| 294 | Novo Nordisk Investigational Site | Osaka | Japan | 565-0874 | |
| 295 | Novo Nordisk Investigational Site | Osaka | Japan | 567-0886 | |
| 296 | Novo Nordisk Investigational Site | Osaka | Japan | 569-0804 | |
| 297 | Novo Nordisk Investigational Site | Osaka | Japan | 569-8585 | |
| 298 | Novo Nordisk Investigational Site | Osaka | Japan | 570-8540 | |
| 299 | Novo Nordisk Investigational Site | Osaka | Japan | 575-8511 | |
| 300 | Novo Nordisk Investigational Site | Osaka | Japan | 577-0802 | |
| 301 | Novo Nordisk Investigational Site | Osaka | Japan | 581-0869 | |
| 302 | Novo Nordisk Investigational Site | Osaka | Japan | 591-8006 | |
| 303 | Novo Nordisk Investigational Site | Osaka | Japan | 598-0011 | |
| 304 | Novo Nordisk Investigational Site | Osaka | Japan | 599-0202 | |
| 305 | Novo Nordisk Investigational Site | Osaka | Japan | 599-8233 | |
| 306 | Novo Nordisk Investigational Site | Osaka | Japan | 599-8247 | |
| 307 | Novo Nordisk Investigational Site | Osaki-shi, Miyagi | Japan | 989-6183 | |
| 308 | Novo Nordisk Investigational Site | Ota-ku, Tokyo | Japan | 1430015 | |
| 309 | Novo Nordisk Investigational Site | Ota-ku, Tokyo | Japan | 144-0051 | |
| 310 | Novo Nordisk Investigational Site | Saga | Japan | 843-0024 | |
| 311 | Novo Nordisk Investigational Site | Saga | Japan | 845-0013 | |
| 312 | Novo Nordisk Investigational Site | Saga | Japan | 847-0012 | |
| 313 | Novo Nordisk Investigational Site | Saga | Japan | 847-0062 | |
| 314 | Novo Nordisk Investigational Site | Saga | Japan | 847-8588 | |
| 315 | Novo Nordisk Investigational Site | Saga | Japan | 849-8577 | |
| 316 | Novo Nordisk Investigational Site | Saitama | Japan | 330-0074 | |
| 317 | Novo Nordisk Investigational Site | Saitama | Japan | 330-0846 | |
| 318 | Novo Nordisk Investigational Site | Saitama | Japan | 330-0855 | |
| 319 | Novo Nordisk Investigational Site | Saitama | Japan | 331-0811 | |
| 320 | Novo Nordisk Investigational Site | Saitama | Japan | 350-1231 | |
| 321 | Novo Nordisk Investigational Site | Saitama | Japan | 350-2201 | |
| 322 | Novo Nordisk Investigational Site | Saitama | Japan | 352-0035 | |
| 323 | Novo Nordisk Investigational Site | Saitama | Japan | 356-0004 | |
| 324 | Novo Nordisk Investigational Site | Saitama | Japan | 356-0057 | |
| 325 | Novo Nordisk Investigational Site | Saitama | Japan | 359-1111 | |
| 326 | Novo Nordisk Investigational Site | Saitama | Japan | 368-0072 | |
| 327 | Novo Nordisk Investigational Site | Sendai-shi, Miyagi | Japan | 983-0824 | |
| 328 | Novo Nordisk Investigational Site | Shiga | Japan | 520-0242 | |
| 329 | Novo Nordisk Investigational Site | Shiga | Japan | 520-0865 | |
| 330 | Novo Nordisk Investigational Site | Shiga | Japan | 523-0082 | |
| 331 | Novo Nordisk Investigational Site | Shiga | Japan | 526-8580 | |
| 332 | Novo Nordisk Investigational Site | Shimane | Japan | 690-0883 | |
| 333 | Novo Nordisk Investigational Site | Shimane | Japan | 691-0044 | |
| 334 | Novo Nordisk Investigational Site | Shimane | Japan | 698-0046 | |
| 335 | Novo Nordisk Investigational Site | Shimotsuga-gun, Tochigi | Japan | 321-0204 | |
| 336 | Novo Nordisk Investigational Site | Shimotsuke-shi, Tochigi | Japan | 329-0433 | |
| 337 | Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | Japan | 162-8655 | |
| 338 | Novo Nordisk Investigational Site | Shinjyuku-ku Tokyo | Japan | 160-0022 | |
| 339 | Novo Nordisk Investigational Site | Shizuoka-city, Shizuoka | Japan | 420-8630 | |
| 340 | Novo Nordisk Investigational Site | Shizuoka | Japan | 410-0041 | |
| 341 | Novo Nordisk Investigational Site | Shizuoka | Japan | 410-0822 | |
| 342 | Novo Nordisk Investigational Site | Shizuoka | Japan | 411-0801 | |
| 343 | Novo Nordisk Investigational Site | Shizuoka | Japan | 411-0816 | |
| 344 | Novo Nordisk Investigational Site | Shizuoka | Japan | 420-0853 | |
| 345 | Novo Nordisk Investigational Site | Shizuoka | Japan | 430-0802 | |
| 346 | Novo Nordisk Investigational Site | Shizuoka | Japan | 431-3113 | |
| 347 | Novo Nordisk Investigational Site | Shizuoka | Japan | 432-8580 | |
| 348 | Novo Nordisk Investigational Site | Soka-shi, Saitama | Japan | 340-0034 | |
| 349 | Novo Nordisk Investigational Site | Suzaka-shi ,Nagano | Japan | 382-0091 | |
| 350 | Novo Nordisk Investigational Site | Tamana-shi, Kumamoto | Japan | 865 0016 | |
| 351 | Novo Nordisk Investigational Site | Tochigi | Japan | 321-1271 | |
| 352 | Novo Nordisk Investigational Site | Tochigi | Japan | 323-0022 | |
| 353 | Novo Nordisk Investigational Site | Tochigi | Japan | 326-0053 | |
| 354 | Novo Nordisk Investigational Site | Tokorozawa-shi,Saitama | Japan | 359-1141 | |
| 355 | Novo Nordisk Investigational Site | Tokushima | Japan | 770-0022 | |
| 356 | Novo Nordisk Investigational Site | Tokushima | Japan | 774-0014 | |
| 357 | Novo Nordisk Investigational Site | Tokushima | Japan | 779-3125 | |
| 358 | Novo Nordisk Investigational Site | Tokyo | Japan | 101-8643 | |
| 359 | Novo Nordisk Investigational Site | Tokyo | Japan | 102-0074 | |
| 360 | Novo Nordisk Investigational Site | Tokyo | Japan | 103-0007 | |
| 361 | Novo Nordisk Investigational Site | Tokyo | Japan | 1040061 | |
| 362 | Novo Nordisk Investigational Site | Tokyo | Japan | 105-0012 | |
| 363 | Novo Nordisk Investigational Site | Tokyo | Japan | 105-8471 | |
| 364 | Novo Nordisk Investigational Site | Tokyo | Japan | 108-0071 | |
| 365 | Novo Nordisk Investigational Site | Tokyo | Japan | 108-8642 | |
| 366 | Novo Nordisk Investigational Site | Tokyo | Japan | 110-0015 | |
| 367 | Novo Nordisk Investigational Site | Tokyo | Japan | 110-0016 | |
| 368 | Novo Nordisk Investigational Site | Tokyo | Japan | 111-0032 | |
| 369 | Novo Nordisk Investigational Site | Tokyo | Japan | 116-0014 | |
| 370 | Novo Nordisk Investigational Site | Tokyo | Japan | 124-0025 | |
| 371 | Novo Nordisk Investigational Site | Tokyo | Japan | 125-8506 | |
| 372 | Novo Nordisk Investigational Site | Tokyo | Japan | 133-0051 | |
| 373 | Novo Nordisk Investigational Site | Tokyo | Japan | 135-0002 | |
| 374 | Novo Nordisk Investigational Site | Tokyo | Japan | 135-0042 | |
| 375 | Novo Nordisk Investigational Site | Tokyo | Japan | 135-8550 | |
| 376 | Novo Nordisk Investigational Site | Tokyo | Japan | 142-0042 | |
| 377 | Novo Nordisk Investigational Site | Tokyo | Japan | 143-0016 | |
| 378 | Novo Nordisk Investigational Site | Tokyo | Japan | 143-8541 | |
| 379 | Novo Nordisk Investigational Site | Tokyo | Japan | 144-0052 | |
| 380 | Novo Nordisk Investigational Site | Tokyo | Japan | 145-0072 | |
| 381 | Novo Nordisk Investigational Site | Tokyo | Japan | 150-0013 | |
| 382 | Novo Nordisk Investigational Site | Tokyo | Japan | 153-0051 | |
| 383 | Novo Nordisk Investigational Site | Tokyo | Japan | 154-0017 | |
| 384 | Novo Nordisk Investigational Site | Tokyo | Japan | 155-0031 | |
| 385 | Novo Nordisk Investigational Site | Tokyo | Japan | 160-8488 | |
| 386 | Novo Nordisk Investigational Site | Tokyo | Japan | 165-8906 | |
| 387 | Novo Nordisk Investigational Site | Tokyo | Japan | 166-0004 | |
| 388 | Novo Nordisk Investigational Site | Tokyo | Japan | 176-8530 | |
| 389 | Novo Nordisk Investigational Site | Tokyo | Japan | 178-0063 | |
| 390 | Novo Nordisk Investigational Site | Tokyo | Japan | 178-0064 | |
| 391 | Novo Nordisk Investigational Site | Tokyo | Japan | 186-0002 | |
| 392 | Novo Nordisk Investigational Site | Tokyo | Japan | 190-0023 | |
| 393 | Novo Nordisk Investigational Site | Tokyo | Japan | 192-0083 | |
| 394 | Novo Nordisk Investigational Site | Tokyo | Japan | 193-0998 | |
| 395 | Novo Nordisk Investigational Site | Tokyo | Japan | 194-0013 | |
| 396 | Novo Nordisk Investigational Site | Tokyo | Japan | 198-0042 | |
| 397 | Novo Nordisk Investigational Site | Tokyo | Japan | 203-0053 | |
| 398 | Novo Nordisk Investigational Site | Tokyo | Japan | 206-0033 | |
| 399 | Novo Nordisk Investigational Site | Tomigusuku-shi, Okinawa | Japan | 901-0244 | |
| 400 | Novo Nordisk Investigational Site | Tottori | Japan | 680-0935 | |
| 401 | Novo Nordisk Investigational Site | Tottori | Japan | 683-8504 | |
| 402 | Novo Nordisk Investigational Site | Toyama-shi, Toyama | Japan | 930-0194 | |
| 403 | Novo Nordisk Investigational Site | Toyama | Japan | 939-0243 | |
| 404 | Novo Nordisk Investigational Site | Toyonaka-shi, Osaka | Japan | 560-0082 | |
| 405 | Novo Nordisk Investigational Site | Wakayama | Japan | 640-8558 | |
| 406 | Novo Nordisk Investigational Site | Yamagata | Japan | 990-8510 | |
| 407 | Novo Nordisk Investigational Site | Yamagata | Japan | 996-0035 | |
| 408 | Novo Nordisk Investigational Site | Yamaguchi | Japan | 740-0034 | |
| 409 | Novo Nordisk Investigational Site | Yamaguchi | Japan | 742-1102 | |
| 410 | Novo Nordisk Investigational Site | Yamaguchi | Japan | 756-0095 | |
| 411 | Novo Nordisk Investigational Site | Yamanashi | Japan | 405-0072 | |
| 412 | Novo Nordisk Investigational Site | Yamato-shi, Kanagawa | Japan | 242-0004 | |
| 413 | Novo Nordisk Investigational Site | Yanagawa-shi, Fukuoka | Japan | 832-0059 | |
| 414 | Novo Nordisk Investigational Site | Yokohama, Kanagawa | Japan | 222-0036 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04469855
Other Study ID Numbers:
- NN9535-4347
- U1111-1187-9072
First Posted:
Jul 14, 2020
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: