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
Enrollment
414
Locations
60.1
Anticipated Duration (Months)
7.2
Patients Per Site
0.1
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase

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

ArmIntervention/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

  1. Number of adverse events (AEs) [From baseline (day 0) to end of study (month 36)]

    Count

Secondary Outcome Measures

  1. Number of serious adverse reactions (SARs) [From baseline (day 0) to end of study (month 36)]

    Count

  2. Number of adverse reactions (ARs) [From baseline (day 0) to end of study (month 36)]

    Count

  3. Number of serious adverse events (SAEs) [From baseline (day 0) to end of study (month 36)]

    Count

  4. Change in glycosylated haemoglobin A1c (HbA1c) [From baseline (day 0) to end of study (month 36)]

    Percent

  5. Change in fasting plasma glucose (FPG) [From baseline (day 0) to end of study (month 36)]

    mg/dL

  6. Change in body weight [From baseline (day 0) to end of study (month 36)]

    kg

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteAichiJapan441-8087
2Novo Nordisk Investigational SiteAichiJapan443-0022
3Novo Nordisk Investigational SiteAichiJapan446-0044
4Novo Nordisk Investigational SiteAichiJapan448-0852
5Novo Nordisk Investigational SiteAichiJapan450-0002
6Novo Nordisk Investigational SiteAichiJapan451-8511
7Novo Nordisk Investigational SiteAichiJapan455-0815
8Novo Nordisk Investigational SiteAichiJapan455-0857
9Novo Nordisk Investigational SiteAichiJapan458-0011
10Novo Nordisk Investigational SiteAichiJapan462-0037
11Novo Nordisk Investigational SiteAichiJapan462-0047
12Novo Nordisk Investigational SiteAichiJapan468-0009
13Novo Nordisk Investigational SiteAichiJapan470-0345
14Novo Nordisk Investigational SiteAichiJapan472-0014
15Novo Nordisk Investigational SiteAichiJapan476-0011
16Novo Nordisk Investigational SiteAichiJapan484-0066
17Novo Nordisk Investigational SiteAichiJapan485-0044
18Novo Nordisk Investigational SiteAichiJapan489-8642
19Novo Nordisk Investigational SiteAkitaJapan016-0014
20Novo Nordisk Investigational SiteAkitaJapan017-8550
21Novo Nordisk Investigational SiteAkitaJapan018-4301
22Novo Nordisk Investigational SiteAomoriJapan030-0823
23Novo Nordisk Investigational SiteAomoriJapan038-0011
24Novo Nordisk Investigational SiteArakawa-ku, TokyoJapan116-0012
25Novo Nordisk Investigational SiteAsahikawa-shi, HokkaidoJapan078-8211
26Novo Nordisk Investigational SiteChiba-shi, ChibaJapan260-0804
27Novo Nordisk Investigational SiteChibaJapan264-0017
28Novo Nordisk Investigational SiteChibaJapan271-0044
29Novo Nordisk Investigational SiteChibaJapan272-0033
30Novo Nordisk Investigational SiteChibaJapan274-0063
31Novo Nordisk Investigational SiteChibaJapan274-0805
32Novo Nordisk Investigational SiteChibaJapan277-0084
33Novo Nordisk Investigational SiteChibaJapan277-8567
34Novo Nordisk Investigational SiteChibaJapan279-0001
35Novo Nordisk Investigational SiteChibaJapan283-0811
36Novo Nordisk Investigational SiteChibaJapan286-0221
37Novo Nordisk Investigational SiteChibaJapan290-0512
38Novo Nordisk Investigational SiteChibaJapan292-0822
39Novo Nordisk Investigational SiteChibaJapan295-0021
40Novo Nordisk Investigational SiteChibaJapan299-1144
41Novo Nordisk Investigational SiteChichibu-cityJapan368-0004
42Novo Nordisk Investigational SiteChitose, HokkaidoJapan066-0032
43Novo Nordisk Investigational SiteEhimeJapan790-0026
44Novo Nordisk Investigational SiteEhimeJapan790-0034
45Novo Nordisk Investigational SiteEhimeJapan791-0281
46Novo Nordisk Investigational SiteEhimeJapan791-8001
47Novo Nordisk Investigational SiteEhimeJapan791-8016
48Novo Nordisk Investigational SiteEhimeJapan791-8026
49Novo Nordisk Investigational SiteEhimeJapan792-0042
50Novo Nordisk Investigational SiteEhimeJapan792-8586
51Novo Nordisk Investigational SiteEhimeJapan794-0054
52Novo Nordisk Investigational SiteEhimeJapan798-8510
53Novo Nordisk Investigational SiteEhimeJapan799-0193
54Novo Nordisk Investigational SiteFukui-shi, FukuiJapan918-8503
55Novo Nordisk Investigational SiteFukuiJapan910-0003
56Novo Nordisk Investigational SiteFukuoka-shi, FukuokaJapan819-0006
57Novo Nordisk Investigational SiteFukuokaJapan800-0296
58Novo Nordisk Investigational SiteFukuokaJapan803-0845
59Novo Nordisk Investigational SiteFukuokaJapan804-0062
60Novo Nordisk Investigational SiteFukuokaJapan805-0031
61Novo Nordisk Investigational SiteFukuokaJapan807-1112
62Novo Nordisk Investigational SiteFukuokaJapan8100001
63Novo Nordisk Investigational SiteFukuokaJapan811-2122
64Novo Nordisk Investigational SiteFukuokaJapan811-3217
65Novo Nordisk Investigational SiteFukuokaJapan812-0053
66Novo Nordisk Investigational SiteFukuokaJapan815-0033
67Novo Nordisk Investigational SiteFukuokaJapan815-0071
68Novo Nordisk Investigational SiteFukuokaJapan818-0072
69Novo Nordisk Investigational SiteFukuokaJapan819-1102
70Novo Nordisk Investigational SiteFukuokaJapan820-0076
71Novo Nordisk Investigational SiteFukuokaJapan825-0002
72Novo Nordisk Investigational SiteFukuokaJapan832-0032
73Novo Nordisk Investigational SiteFukuokaJapan833-0041
74Novo Nordisk Investigational SiteFukuokaJapan834-0115
75Novo Nordisk Investigational SiteFukushima-shi, FukushimaJapan960-8001
76Novo Nordisk Investigational SiteFukushimaJapan961-8031
77Novo Nordisk Investigational SiteFukushimaJapan963-8851
78Novo Nordisk Investigational SiteFukushimaJapan965-0853
79Novo Nordisk Investigational SiteFukushimaJapan973-8402
80Novo Nordisk Investigational SiteGifu-shi, GifuJapan501-1194
81Novo Nordisk Investigational SiteGifuJapan500-8381
82Novo Nordisk Investigational SiteGifuJapan501-6003
83Novo Nordisk Investigational SiteGifuJapan501-6018
84Novo Nordisk Investigational SiteGifuJapan501-6062
85Novo Nordisk Investigational SiteGifuJapan504-0829
86Novo Nordisk Investigational SiteGifuJapan506-0053
87Novo Nordisk Investigational SiteGummaJapan370-3573
88Novo Nordisk Investigational SiteGummaJapan372-0007
89Novo Nordisk Investigational SiteGummaJapan372-0812
90Novo Nordisk Investigational SiteGummaJapan373-0852
91Novo Nordisk Investigational SiteGunmaJapan370-0069
92Novo Nordisk Investigational SiteGunmaJapan373-0036
93Novo Nordisk Investigational SiteGunmaJapan374-0052
94Novo Nordisk Investigational SiteHigashiosaka-shi, OsakaJapan577 0803
95Novo Nordisk Investigational SiteHiroshimaJapan720-1131
96Novo Nordisk Investigational SiteHiroshimaJapan722-0002
97Novo Nordisk Investigational SiteHiroshimaJapan722-0014
98Novo Nordisk Investigational SiteHiroshimaJapan730-8619
99Novo Nordisk Investigational SiteHiroshimaJapan733-0033
100Novo Nordisk Investigational SiteHiroshimaJapan739-0041
101Novo Nordisk Investigational SiteHokkaidoJapan041-0821
102Novo Nordisk Investigational SiteHokkaidoJapan047-0021
103Novo Nordisk Investigational SiteHokkaidoJapan053-0042
104Novo Nordisk Investigational SiteHokkaidoJapan060-0004
105Novo Nordisk Investigational SiteHokkaidoJapan060-0042
106Novo Nordisk Investigational SiteHokkaidoJapan060-0807
107Novo Nordisk Investigational SiteHokkaidoJapan063-0005
108Novo Nordisk Investigational SiteHokkaidoJapan064-0824
109Novo Nordisk Investigational SiteHokkaidoJapan064-0917
110Novo Nordisk Investigational SiteHokkaidoJapan068-0021
111Novo Nordisk Investigational SiteHokkaidoJapan070-8530
112Novo Nordisk Investigational SiteHokkaidoJapan073-1105
113Novo Nordisk Investigational SiteHokkaidoJapan078-8234
114Novo Nordisk Investigational SiteHokkaidoJapan080 0810
115Novo Nordisk Investigational SiteHosu-gun, IshikawaJapan927-0053
116Novo Nordisk Investigational SiteHyogogokenJapan670-0837
117Novo Nordisk Investigational SiteHyogoJapan650-0002
118Novo Nordisk Investigational SiteHyogoJapan651-2135
119Novo Nordisk Investigational SiteHyogoJapan656-0026
120Novo Nordisk Investigational SiteHyogoJapan658-0064
121Novo Nordisk Investigational SiteHyogoJapan658-0084
122Novo Nordisk Investigational SiteHyogoJapan659-8502
123Novo Nordisk Investigational SiteHyogoJapan660-0861
124Novo Nordisk Investigational SiteHyogoJapan660-0892
125Novo Nordisk Investigational SiteHyogoJapan661-0976
126Novo Nordisk Investigational SiteHyogoJapan662-0075
127Novo Nordisk Investigational SiteHyogoJapan665-0861
128Novo Nordisk Investigational SiteHyogoJapan670-0053
129Novo Nordisk Investigational SiteHyogoJapan670-0801
130Novo Nordisk Investigational SiteHyogoJapan672-8035
131Novo Nordisk Investigational SiteHyogoJapan673-0891
132Novo Nordisk Investigational SiteHyogoJapan674-0063
133Novo Nordisk Investigational SiteHyogoJapan675-0156
134Novo Nordisk Investigational SiteHyogoJapan675-0314
135Novo Nordisk Investigational SiteHyogoJapan675-1316
136Novo Nordisk Investigational SiteHyogoJapan675-8555
137Novo Nordisk Investigational SiteHyogoJapan678-0226
138Novo Nordisk Investigational SiteHyogoJapan678-0232
139Novo Nordisk Investigational SiteIbarakiJapan300-0012
140Novo Nordisk Investigational SiteIbarakiJapan300-0395
141Novo Nordisk Investigational SiteIbarakiJapan300-0504
142Novo Nordisk Investigational SiteIbarakiJapan306-0232
143Novo Nordisk Investigational SiteIbarakiJapan309-1703
144Novo Nordisk Investigational SiteIbarakiJapan310-0015
145Novo Nordisk Investigational SiteIbarakiJapan311-0113
146Novo Nordisk Investigational SiteIbarakiJapan314-0031
147Novo Nordisk Investigational SiteImizu-shiJapan939 0363
148Novo Nordisk Investigational SiteIruma-shi, SaitamaJapan358 0003
149Novo Nordisk Investigational SiteIshikawaJapan920-0012
150Novo Nordisk Investigational SiteIshikawaJapan920-0293
151Novo Nordisk Investigational SiteIwateJapan020-0403
152Novo Nordisk Investigational SiteIwateJapan021-0002
153Novo Nordisk Investigational SiteIwateJapan024-0061
154Novo Nordisk Investigational SiteIwateJapan028-3695
155Novo Nordisk Investigational SiteIzumisano-shiJapan598 0048
156Novo Nordisk Investigational SiteKagawaJapan760-8557
157Novo Nordisk Investigational SiteKagawaJapan761-1701
158Novo Nordisk Investigational SiteKagawaJapan762-0038
159Novo Nordisk Investigational SiteKagawaJapan765-0052
160Novo Nordisk Investigational SiteKagawaJapan765-0071
161Novo Nordisk Investigational SiteKagawaJapan769-2401
162Novo Nordisk Investigational SiteKagoshima-shi, KagoshimaJapan890-0061
163Novo Nordisk Investigational SiteKagoshimaJapan890-0073
164Novo Nordisk Investigational SiteKagoshimaJapan891-0133
165Novo Nordisk Investigational SiteKagoshimaJapan893-0014
166Novo Nordisk Investigational SiteKagoshimaJapan893-0022
167Novo Nordisk Investigational SiteKagoshimaJapan895-0052
168Novo Nordisk Investigational SiteKagoshimaJapan899-0214
169Novo Nordisk Investigational SiteKagoshimaJapan899-5421
170Novo Nordisk Investigational SiteKamakura-shiJapan247 0056
171Novo Nordisk Investigational SiteKanagawaJapan211-0004
172Novo Nordisk Investigational SiteKanagawaJapan211-0041
173Novo Nordisk Investigational SiteKanagawaJapan213-8507
174Novo Nordisk Investigational SiteKanagawaJapan214-0014
175Novo Nordisk Investigational SiteKanagawaJapan222-0033
176Novo Nordisk Investigational SiteKanagawaJapan223-0052
177Novo Nordisk Investigational SiteKanagawaJapan231-8682
178Novo Nordisk Investigational SiteKanagawaJapan235-0045
179Novo Nordisk Investigational SiteKanagawaJapan236-0033
180Novo Nordisk Investigational SiteKanagawaJapan236-0037
181Novo Nordisk Investigational SiteKanagawaJapan236-0058
182Novo Nordisk Investigational SiteKanagawaJapan243-0035
183Novo Nordisk Investigational SiteKanagawaJapan245-8575
184Novo Nordisk Investigational SiteKanagawaJapan247-0055
185Novo Nordisk Investigational SiteKanagawaJapan250-8558
186Novo Nordisk Investigational SiteKanagawaJapan251-0052
187Novo Nordisk Investigational SiteKanagawaJapan252-0131
188Novo Nordisk Investigational SiteKanagawaJapan252-0302
189Novo Nordisk Investigational SiteKanagawaJapan253-0042
190Novo Nordisk Investigational SiteKanagawaJapan254-8502
191Novo Nordisk Investigational SiteKanagawaJapan256-0816
192Novo Nordisk Investigational SiteKanagawaJapan259-1126
193Novo Nordisk Investigational SiteKanagawaJapan259-1193
194Novo Nordisk Investigational SiteKawagoe-shi, SaitamaJapan350-0851
195Novo Nordisk Investigational SiteKawasaki-shiJapan212 0024
196Novo Nordisk Investigational SiteKisarazu-shi, ChibaJapan292-0038
197Novo Nordisk Investigational SiteKobe, HyogoJapan650-0017
198Novo Nordisk Investigational SiteKochiJapan780-0843
199Novo Nordisk Investigational SiteKoshigaya-shi,SaitamaJapan343 0828
200Novo Nordisk Investigational SiteKumamotoJapan862-0976
201Novo Nordisk Investigational SiteKumamotoJapan865-0064
202Novo Nordisk Investigational SiteKumamotoJapan867-0041
203Novo Nordisk Investigational SiteKyotoJapan601-8325
204Novo Nordisk Investigational SiteKyotoJapan604-0884
205Novo Nordisk Investigational SiteKyotoJapan604-8416
206Novo Nordisk Investigational SiteKyotoJapan606-0025
207Novo Nordisk Investigational SiteKyotoJapan607-8494
208Novo Nordisk Investigational SiteKyotoJapan612-0875
209Novo Nordisk Investigational SiteKyotoJapan619-0224
210Novo Nordisk Investigational SiteKyotoJapan623-0011
211Novo Nordisk Investigational SiteMieJapan514-1101
212Novo Nordisk Investigational SiteMieJapan514-8507
213Novo Nordisk Investigational SiteMieJapan516-0035
214Novo Nordisk Investigational SiteMieJapan516-8512
215Novo Nordisk Investigational SiteMinato-kuJapan108 0073
216Novo Nordisk Investigational SiteMitaka-shi, TokyoJapan181-0013
217Novo Nordisk Investigational SiteMiura-shi, KanagawaJapan238-0101
218Novo Nordisk Investigational SiteMiyagiJapan981-3133
219Novo Nordisk Investigational SiteMiyagiJapan982-0011
220Novo Nordisk Investigational SiteMiyagiJapan985-0863
221Novo Nordisk Investigational SiteMiyagiJapan988-0084
222Novo Nordisk Investigational SiteMiyazakiJapan880-0034
223Novo Nordisk Investigational SiteMiyazakiJapan880-0041
224Novo Nordisk Investigational SiteMiyazakiJapan880-0806
225Novo Nordisk Investigational SiteMiyazakiJapan889-3141
226Novo Nordisk Investigational SiteMiyazakiJapan889-4505
227Novo Nordisk Investigational SiteMuroran-shi, HokkaidoJapan050-0073
228Novo Nordisk Investigational SiteNaganoJapan385-8558
229Novo Nordisk Investigational SiteNaganoJapan386-0004
230Novo Nordisk Investigational SiteNaganoJapan386-8610
231Novo Nordisk Investigational SiteNaganoJapan395-8502
232Novo Nordisk Investigational SiteNaganoJapan395-8522
233Novo Nordisk Investigational SiteNaganoJapan396-0033
234Novo Nordisk Investigational SiteNagasakiJapan850-0003
235Novo Nordisk Investigational SiteNagasakiJapan850-0831
236Novo Nordisk Investigational SiteNagasakiJapan851-0405
237Novo Nordisk Investigational SiteNagasakiJapan852-8042
238Novo Nordisk Investigational SiteNagasakiJapan852-8107
239Novo Nordisk Investigational SiteNagasakiJapan852-8511
240Novo Nordisk Investigational SiteNagasakiJapan856-0831
241Novo Nordisk Investigational SiteNagasakiJapan857-8511
242Novo Nordisk Investigational SiteNaraJapan631-0003
243Novo Nordisk Investigational SiteNaraJapan631-0036
244Novo Nordisk Investigational SiteNaraJapan631-0813
245Novo Nordisk Investigational SiteNaraJapan631-0842
246Novo Nordisk Investigational SiteNaraJapan633-0064
247Novo Nordisk Investigational SiteNaraJapan635-0015
248Novo Nordisk Investigational SiteNaraJapan635-0825
249Novo Nordisk Investigational SiteNaraJapan636-0081
250Novo Nordisk Investigational SiteNaraJapan639-2251
251Novo Nordisk Investigational SiteNiigata-shi, NiigataJapan950-1104
252Novo Nordisk Investigational SiteNiigataJapan942-0052
253Novo Nordisk Investigational SiteNiigataJapan943-0893
254Novo Nordisk Investigational SiteNiigataJapan949-3443
255Novo Nordisk Investigational SiteNiigataJapan959-3193
256Novo Nordisk Investigational SiteNishinomiya-shi, HyogoJapan663-8501
257Novo Nordisk Investigational SiteOita-shiJapan870 0039
258Novo Nordisk Investigational SiteOitaJapan870 8511
259Novo Nordisk Investigational SiteOitaJapan870-0935
260Novo Nordisk Investigational SiteOitaJapan875-0051
261Novo Nordisk Investigational SiteOitaJapan879-0627
262Novo Nordisk Investigational SiteOitaJapan879-7301
263Novo Nordisk Investigational SiteOkayama-shi, OkayamaJapan701-1192
264Novo Nordisk Investigational SiteOkayamaJapan700-8558
265Novo Nordisk Investigational SiteOkayamaJapan708-0806
266Novo Nordisk Investigational SiteOkayamaJapan710-0051
267Novo Nordisk Investigational SiteOkayamaJapan711-0923
268Novo Nordisk Investigational SiteOkayamaJapan714-0043
269Novo Nordisk Investigational SiteOkinawaJapan901-2131
270Novo Nordisk Investigational SiteOkinawaJapan902-0062
271Novo Nordisk Investigational SiteOkinawaJapan904-2143
272Novo Nordisk Investigational SiteOkinawaJapan904-2244
273Novo Nordisk Investigational SiteOkinawaJapan905-0018
274Novo Nordisk Investigational SiteOsaka-shi, OsakaJapan532 0003
275Novo Nordisk Investigational SiteOsaka-shi, OsakaJapan533-0024
276Novo Nordisk Investigational SiteOsaka-shi, OsakaJapan536-0001
277Novo Nordisk Investigational SiteOsakaJapan530-0004
278Novo Nordisk Investigational SiteOsakaJapan530-0012
279Novo Nordisk Investigational SiteOsakaJapan533-0001
280Novo Nordisk Investigational SiteOsakaJapan534-0021
281Novo Nordisk Investigational SiteOsakaJapan536-0002
282Novo Nordisk Investigational SiteOsakaJapan540-0006
283Novo Nordisk Investigational SiteOsakaJapan543-0014
284Novo Nordisk Investigational SiteOsakaJapan543-0035
285Novo Nordisk Investigational SiteOsakaJapan545-8586
286Novo Nordisk Investigational SiteOsakaJapan553-0002
287Novo Nordisk Investigational SiteOsakaJapan553-0003
288Novo Nordisk Investigational SiteOsakaJapan558-0013
289Novo Nordisk Investigational SiteOsakaJapan558-8558
290Novo Nordisk Investigational SiteOsakaJapan561-0833
291Novo Nordisk Investigational SiteOsakaJapan561-0884
292Novo Nordisk Investigational SiteOsakaJapan563-0033
293Novo Nordisk Investigational SiteOsakaJapan565-0842
294Novo Nordisk Investigational SiteOsakaJapan565-0874
295Novo Nordisk Investigational SiteOsakaJapan567-0886
296Novo Nordisk Investigational SiteOsakaJapan569-0804
297Novo Nordisk Investigational SiteOsakaJapan569-8585
298Novo Nordisk Investigational SiteOsakaJapan570-8540
299Novo Nordisk Investigational SiteOsakaJapan575-8511
300Novo Nordisk Investigational SiteOsakaJapan577-0802
301Novo Nordisk Investigational SiteOsakaJapan581-0869
302Novo Nordisk Investigational SiteOsakaJapan591-8006
303Novo Nordisk Investigational SiteOsakaJapan598-0011
304Novo Nordisk Investigational SiteOsakaJapan599-0202
305Novo Nordisk Investigational SiteOsakaJapan599-8233
306Novo Nordisk Investigational SiteOsakaJapan599-8247
307Novo Nordisk Investigational SiteOsaki-shi, MiyagiJapan989-6183
308Novo Nordisk Investigational SiteOta-ku, TokyoJapan1430015
309Novo Nordisk Investigational SiteOta-ku, TokyoJapan144-0051
310Novo Nordisk Investigational SiteSagaJapan843-0024
311Novo Nordisk Investigational SiteSagaJapan845-0013
312Novo Nordisk Investigational SiteSagaJapan847-0012
313Novo Nordisk Investigational SiteSagaJapan847-0062
314Novo Nordisk Investigational SiteSagaJapan847-8588
315Novo Nordisk Investigational SiteSagaJapan849-8577
316Novo Nordisk Investigational SiteSaitamaJapan330-0074
317Novo Nordisk Investigational SiteSaitamaJapan330-0846
318Novo Nordisk Investigational SiteSaitamaJapan330-0855
319Novo Nordisk Investigational SiteSaitamaJapan331-0811
320Novo Nordisk Investigational SiteSaitamaJapan350-1231
321Novo Nordisk Investigational SiteSaitamaJapan350-2201
322Novo Nordisk Investigational SiteSaitamaJapan352-0035
323Novo Nordisk Investigational SiteSaitamaJapan356-0004
324Novo Nordisk Investigational SiteSaitamaJapan356-0057
325Novo Nordisk Investigational SiteSaitamaJapan359-1111
326Novo Nordisk Investigational SiteSaitamaJapan368-0072
327Novo Nordisk Investigational SiteSendai-shi, MiyagiJapan983-0824
328Novo Nordisk Investigational SiteShigaJapan520-0242
329Novo Nordisk Investigational SiteShigaJapan520-0865
330Novo Nordisk Investigational SiteShigaJapan523-0082
331Novo Nordisk Investigational SiteShigaJapan526-8580
332Novo Nordisk Investigational SiteShimaneJapan690-0883
333Novo Nordisk Investigational SiteShimaneJapan691-0044
334Novo Nordisk Investigational SiteShimaneJapan698-0046
335Novo Nordisk Investigational SiteShimotsuga-gun, TochigiJapan321-0204
336Novo Nordisk Investigational SiteShimotsuke-shi, TochigiJapan329-0433
337Novo Nordisk Investigational SiteShinjuku-ku, TokyoJapan162-8655
338Novo Nordisk Investigational SiteShinjyuku-ku TokyoJapan160-0022
339Novo Nordisk Investigational SiteShizuoka-city, ShizuokaJapan420-8630
340Novo Nordisk Investigational SiteShizuokaJapan410-0041
341Novo Nordisk Investigational SiteShizuokaJapan410-0822
342Novo Nordisk Investigational SiteShizuokaJapan411-0801
343Novo Nordisk Investigational SiteShizuokaJapan411-0816
344Novo Nordisk Investigational SiteShizuokaJapan420-0853
345Novo Nordisk Investigational SiteShizuokaJapan430-0802
346Novo Nordisk Investigational SiteShizuokaJapan431-3113
347Novo Nordisk Investigational SiteShizuokaJapan432-8580
348Novo Nordisk Investigational SiteSoka-shi, SaitamaJapan340-0034
349Novo Nordisk Investigational SiteSuzaka-shi ,NaganoJapan382-0091
350Novo Nordisk Investigational SiteTamana-shi, KumamotoJapan865 0016
351Novo Nordisk Investigational SiteTochigiJapan321-1271
352Novo Nordisk Investigational SiteTochigiJapan323-0022
353Novo Nordisk Investigational SiteTochigiJapan326-0053
354Novo Nordisk Investigational SiteTokorozawa-shi,SaitamaJapan359-1141
355Novo Nordisk Investigational SiteTokushimaJapan770-0022
356Novo Nordisk Investigational SiteTokushimaJapan774-0014
357Novo Nordisk Investigational SiteTokushimaJapan779-3125
358Novo Nordisk Investigational SiteTokyoJapan101-8643
359Novo Nordisk Investigational SiteTokyoJapan102-0074
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364Novo Nordisk Investigational SiteTokyoJapan108-0071
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374Novo Nordisk Investigational SiteTokyoJapan135-0042
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376Novo Nordisk Investigational SiteTokyoJapan142-0042
377Novo Nordisk Investigational SiteTokyoJapan143-0016
378Novo Nordisk Investigational SiteTokyoJapan143-8541
379Novo Nordisk Investigational SiteTokyoJapan144-0052
380Novo Nordisk Investigational SiteTokyoJapan145-0072
381Novo Nordisk Investigational SiteTokyoJapan150-0013
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383Novo Nordisk Investigational SiteTokyoJapan154-0017
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397Novo Nordisk Investigational SiteTokyoJapan203-0053
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399Novo Nordisk Investigational SiteTomigusuku-shi, OkinawaJapan901-0244
400Novo Nordisk Investigational SiteTottoriJapan680-0935
401Novo Nordisk Investigational SiteTottoriJapan683-8504
402Novo Nordisk Investigational SiteToyama-shi, ToyamaJapan930-0194
403Novo Nordisk Investigational SiteToyamaJapan939-0243
404Novo Nordisk Investigational SiteToyonaka-shi, OsakaJapan560-0082
405Novo Nordisk Investigational SiteWakayamaJapan640-8558
406Novo Nordisk Investigational SiteYamagataJapan990-8510
407Novo Nordisk Investigational SiteYamagataJapan996-0035
408Novo Nordisk Investigational SiteYamaguchiJapan740-0034
409Novo Nordisk Investigational SiteYamaguchiJapan742-1102
410Novo Nordisk Investigational SiteYamaguchiJapan756-0095
411Novo Nordisk Investigational SiteYamanashiJapan405-0072
412Novo Nordisk Investigational SiteYamato-shi, KanagawaJapan242-0004
413Novo Nordisk Investigational SiteYanagawa-shi, FukuokaJapan832-0059
414Novo Nordisk Investigational SiteYokohama, KanagawaJapan222-0036

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:
Oct 5, 2021
Last Verified:
Oct 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:

Study Results

No Results Posted as of Oct 5, 2021