SOUL: A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03914326
Collaborator
(none)
9,642
445
2
61.4
21.7
0.4

Study Details

Study Description

Brief Summary

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9642 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose:
Treatment
Official Title:
Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
Actual Study Start Date :
Jun 17, 2019
Anticipated Primary Completion Date :
Jul 29, 2024
Anticipated Study Completion Date :
Jul 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oral semaglutide

One tablet daily for 3.5 to 5 years

Drug: Semaglutide
Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state

Placebo Comparator: Placebo

One tablet daily for 3.5 to 5 years

Drug: Placebo (semaglutide)
Placebo tablets to be taken with water at the same time every morning in a fasting state

Outcome Measures

Primary Outcome Measures

  1. Time to first occurrence of a major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death/non-fatal myocardial infarction/non-fatal stroke [From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven)]

    Months

Secondary Outcome Measures

  1. Time to first occurrence of a composite endpoint [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Time to first occurrence of a composite endpoint consisting of: CV death/renal death/onset of persistent 50% or more reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (compared with baseline)/onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2/initiation of chronic renal replacement therapy (dialysis or kidney transplantation). Unit of assessment: Months

  2. Time to occurrence of CV death [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  3. Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  4. Time to first occurrence of an expanded MACE composite endpoint consisting of: CV death/non-fatal myocardial infarction/ non-fatal stroke/coronary revascularisation/unstable angina requiring hospitalisation [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  5. Time to first occurrence of a composite heart failure endpoint consisting of: CV death/heart failure requiring hospitalisation/urgent heart failure visit [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  6. Time to first occurrence of a composite CKD endpoint [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Time to first occurrence of a composite CKD endpoint consisting of: renal death/onset of persistent 50% or more reduction in eGFR (CKD-EPI)/onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2/initiation of chronic renal replacement therapy (dialysis or kidney transplantation). Unit of assessment: Months

  7. Time to occurrence of all-cause death [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  8. Time to first occurrence of non-fatal myocardial infarction (MI) [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  9. Time to first occurrence of non-fatal stroke [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  10. Time to first occurrence of heart failure requiring hospitalisation [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  11. Time to first occurrence of urgent heart failure visit [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  12. Time to first occurrence of coronary revascularisation [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  13. Time to first occurrence of unstable angina requiring hospitalisation [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  14. Time to occurrence of renal death [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  15. Time to first occurrence of onset of persistent 50% or more reduction in eGFR [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  16. Time to first occurrence of onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2 [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  17. Time to first occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  18. Time to first occurrence of a composite endpoint consisting of: all-cause death/non-fatal myocardial infarction/non-fatal stroke [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  19. Time to first occurrence of acute limb ischemia [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  20. Time to first occurrence of chronic limb ischemia [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

  21. Annual rate of change in eGFR (CKD-EPI) (total eGFR slope) [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    ml/min/1.73 m^2 per year

  22. Change in glycosylated haemoglobin (HbA1c) [From randomisation (week 0) to 2 years]

    Percent points

  23. Change in body weight [From randomisation (week 0) to 2 years]

    Kilograms

  24. Number of severe hypoglycaemic episodes [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Number of events

  25. Time to first occurrence of a severe hypoglycaemic episode [From randomisation (week 0) to end-of-trial (up to 61 months or more)]

    Months

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female, age equal to or above 50 years at the time of signing informed consent

  • Diagnosed with type 2 diabetes mellitus

  • HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement)

  • At least one of the below conditions (a-d):

  1. Coronary heart disease defined as at least one of the following: i. Prior myocardial infarction ii. Prior coronary revascularisation procedure iii. 50% or above stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke ii. Prior carotid artery revascularisation procedure iii.50% or above stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) d) Chronic kidney disease defined as: i. eGFR below 60 mL/min/1.73 m^2 (based on medical records using latest available and no more than 6 months old assessment)
Exclusion Criteria:
  • Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening

  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening

  • Heart failure presently classified as being in New York Heart Association Class IV

  • Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Montgomery Alabama United States 36106
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3 Novo Nordisk Investigational Site Searcy Arkansas United States 72143
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154 Novo Nordisk Investigational Site Osijek Croatia 31 000
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157 Novo Nordisk Investigational Site Split Croatia 21 000
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161 Novo Nordisk Investigational Site Zagreb Croatia 10000
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172 Novo Nordisk Investigational Site Hillerød Denmark 3400
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185 Novo Nordisk Investigational Site Dresden Germany 01307
186 Novo Nordisk Investigational Site Essen Germany 45219
187 Novo Nordisk Investigational Site Falkensee Germany 14612
188 Novo Nordisk Investigational Site Hamburg Germany 21073
189 Novo Nordisk Investigational Site Hamburg Germany 22041
190 Novo Nordisk Investigational Site Jerichow Germany 39319
191 Novo Nordisk Investigational Site Lingen Germany 49808
192 Novo Nordisk Investigational Site Ludwigshafen Germany 67059
193 Novo Nordisk Investigational Site Münster Germany 48145
194 Novo Nordisk Investigational Site Oldenburg I. Holst Germany 23758
195 Novo Nordisk Investigational Site Rehlingen-Siersburg Germany 66780
196 Novo Nordisk Investigational Site Stuttgart Germany 70199
197 Novo Nordisk Investigational Site Witten Germany 58455
198 Novo Nordisk Investigational Site Shatin, New Territories Hong Kong 999077
199 Novo Nordisk Investigational Site Hyderabad Andhra Pradesh India 500034
200 Novo Nordisk Investigational Site Hyderabad Andhra Pradesh India 500072
201 Novo Nordisk Investigational Site Secunderabad, Andhra Pradesh India 500003
202 Novo Nordisk Investigational Site Guwahati Assam India 781033
203 Novo Nordisk Investigational Site Ahmedabad Gujarat India 380006
204 Novo Nordisk Investigational Site Ahmedabad Gujarat India 380007
205 Novo Nordisk Investigational Site Rohtak Haryana India 124001
206 Novo Nordisk Investigational Site Bangalore Karnataka India 560054
207 Novo Nordisk Investigational Site Bangalore Karnataka India 560092
208 Novo Nordisk Investigational Site Kozhikode Kerala India 673017
209 Novo Nordisk Investigational Site Indore Madhya Pradesh India 452010
210 Novo Nordisk Investigational Site Goa Maharashtra India 403 202
211 Novo Nordisk Investigational Site Mumbai Maharashtra India 4000016
212 Novo Nordisk Investigational Site Mumbai Maharashtra India 400008
213 Novo Nordisk Investigational Site Mumbai Maharashtra India 400058
214 Novo Nordisk Investigational Site Mumbai Maharashtra India 400078
215 Novo Nordisk Investigational Site Pune Maharashtra India 411021
216 Novo Nordisk Investigational Site Pune Maharashtra India 411040
217 Novo Nordisk Investigational Site New Dehli New Delhi India 110029
218 Novo Nordisk Investigational Site Bhubaneswar Orissa India 751019
219 Novo Nordisk Investigational Site Ludhiana Punjab India 141008
220 Novo Nordisk Investigational Site Mohali Punjab India 160062
221 Novo Nordisk Investigational Site Jaipur Rajasthan India 302006
222 Novo Nordisk Investigational Site Chennai Tamil Nadu India 600086
223 Novo Nordisk Investigational Site Coimbatore Tamil Nadu India 641018
224 Novo Nordisk Investigational Site Vellore Tamil Nadu India 632004
225 Novo Nordisk Investigational Site Hyderabad Telengana India 500003
226 Novo Nordisk Investigational Site Kolkata West Bengal India 700020
227 Novo Nordisk Investigational Site Kolkata West Bengal India 700054
228 Novo Nordisk Investigational Site Hyderabad India 500 012
229 Novo Nordisk Investigational Site Ludhiana India 141001
230 Novo Nordisk Investigational Site New Delhi India 110001
231 Novo Nordisk Investigational Site New Delhi India 110085
232 Novo Nordisk Investigational Site Thriruvananthapuram India 695 032
233 Novo Nordisk Investigational Site Haifa Israel 31096
234 Novo Nordisk Investigational Site Jerusalem Israel 91120
235 Novo Nordisk Investigational Site Jerusalem Israel 93106
236 Novo Nordisk Investigational Site Kfar Saba Israel 44281
237 Novo Nordisk Investigational Site Nahariya Israel 22100
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239 Novo Nordisk Investigational Site Tel Hashomer Israel 52621
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242 Novo Nordisk Investigational Site Bari Italy 70124
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244 Novo Nordisk Investigational Site Chieti Italy 66100
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246 Novo Nordisk Investigational Site Milano Italy 20132
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249 Novo Nordisk Investigational Site Padova Italy 35128
250 Novo Nordisk Investigational Site Palermo Italy 90127
251 Novo Nordisk Investigational Site Palermo Italy 90129
252 Novo Nordisk Investigational Site Perugia Italy 06129
253 Novo Nordisk Investigational Site Roma Italy 00133
254 Novo Nordisk Investigational Site Roma Italy 00161
255 Novo Nordisk Investigational Site Bunkyo-ku, Tokyo Japan 113-8655
256 Novo Nordisk Investigational Site Chiba Japan 271-0077
257 Novo Nordisk Investigational Site Ehime Japan 790-0024
258 Novo Nordisk Investigational Site Fukui Japan 910-0846
259 Novo Nordisk Investigational Site Fukuoka Japan 816-0864
260 Novo Nordisk Investigational Site Ibaraki Japan 311-0113
261 Novo Nordisk Investigational Site Kumamoto Japan 862-0976
262 Novo Nordisk Investigational Site Kyoto-shi, Kyoto Japan 606-8507
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264 Novo Nordisk Investigational Site Miyagi Japan 983-0039
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270 Novo Nordisk Investigational Site Osaka Japan 574-0074
271 Novo Nordisk Investigational Site Saga-shi, Saga Japan 849-8501
272 Novo Nordisk Investigational Site Sapporo-shi, Hokkaido Japan 062-0003
273 Novo Nordisk Investigational Site Takamatsu-shi, Kagawa Japan 760-8557
274 Novo Nordisk Investigational Site Tochigi Japan 323-0022
275 Novo Nordisk Investigational Site Tokorozawa-shi, Saitama Japan 356-1142
276 Novo Nordisk Investigational Site Tokyo Japan 103-0027
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280 Novo Nordisk Investigational Site Tokyo Japan 196-0003
281 Novo Nordisk Investigational Site Gyeonggi-do Korea, Republic of 13620
282 Novo Nordisk Investigational Site Gyeonggi-do Korea, Republic of 471-101
283 Novo Nordisk Investigational Site Seoul Korea, Republic of 02841
284 Novo Nordisk Investigational Site Seoul Korea, Republic of 03722
285 Novo Nordisk Investigational Site Seoul Korea, Republic of 05505
286 Novo Nordisk Investigational Site Seoul Korea, Republic of 06591
287 Novo Nordisk Investigational Site Seoul Korea, Republic of 139-827
288 Novo Nordisk Investigational Site Alor Setar Malaysia 05460
289 Novo Nordisk Investigational Site Kota Bharu, Kelantan Malaysia 16150
290 Novo Nordisk Investigational Site Kota Bharu Malaysia 15586
291 Novo Nordisk Investigational Site Kota Samarahan Malaysia 94300
292 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 59100
293 Novo Nordisk Investigational Site Kuching Malaysia 93586
294 Novo Nordisk Investigational Site Putrajaya Malaysia 62250
295 Novo Nordisk Investigational Site Sarawak Malaysia 98000
296 Novo Nordisk Investigational Site Seremban Malaysia 70300
297 Novo Nordisk Investigational Site Sungai Buloh Malaysia 47000
298 Novo Nordisk Investigational Site Guadalajara Jalisco Mexico 44600
299 Novo Nordisk Investigational Site Guadalajara Jalisco Mexico 44650
300 Novo Nordisk Investigational Site Tlalpan México, D.F. Mexico 14080
301 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64020
302 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64060
303 Novo Nordisk Investigational Site San Nicolas de los Garza Nuevo León Mexico 66465
304 Novo Nordisk Investigational Site Hermosillo Sonora Mexico 83280
305 Novo Nordisk Investigational Site Merida Yucatan Mexico 97070
306 Novo Nordisk Investigational Site Mérida Yucatan Mexico 97070
307 Novo Nordisk Investigational Site Aguascalientes Mexico 20230
308 Novo Nordisk Investigational Site Amersfoort Netherlands 3813 TZ
309 Novo Nordisk Investigational Site Amsterdam Netherlands 1081 HV
310 Novo Nordisk Investigational Site Apeldoorn Netherlands 7334 DZ
311 Novo Nordisk Investigational Site Delft Netherlands 2625 AD
312 Novo Nordisk Investigational Site Eindhoven Netherlands 5631 BM
313 Novo Nordisk Investigational Site Groningen Netherlands 9728 NT
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315 Novo Nordisk Investigational Site Maastricht Netherlands 6229 HX
316 Novo Nordisk Investigational Site Nijmegen Netherlands 6525 GA
317 Novo Nordisk Investigational Site Utrecht Netherlands 3584 CX
318 Novo Nordisk Investigational Site Cluj Napoca Cluj Romania 400006
319 Novo Nordisk Investigational Site Targoviste Dambovita Romania 130086
320 Novo Nordisk Investigational Site Targu Mures Mures Romania 540136
321 Novo Nordisk Investigational Site Tirgu Mures Mures Romania 540142
322 Novo Nordisk Investigational Site Ploiesti Prahova Romania 100018
323 Novo Nordisk Investigational Site Ploiesti Prahova Romania 100342
324 Novo Nordisk Investigational Site Bacau Romania 600154
325 Novo Nordisk Investigational Site Bucharest Romania 051811
326 Novo Nordisk Investigational Site Galati Romania 800578
327 Novo Nordisk Investigational Site Iasi Romania 700111
328 Novo Nordisk Investigational Site Sibiu Romania 550371
329 Novo Nordisk Investigational Site Barnaul Russian Federation 656045
330 Novo Nordisk Investigational Site Kazan Russian Federation 420012
331 Novo Nordisk Investigational Site Kazan Russian Federation 420111
332 Novo Nordisk Investigational Site Kemerovo Russian Federation 650066
333 Novo Nordisk Investigational Site Moscow Russian Federation 117292
334 Novo Nordisk Investigational Site Moscow Russian Federation 119435
335 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630087
336 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630099
337 Novo Nordisk Investigational Site Penza Russian Federation 440026
338 Novo Nordisk Investigational Site Saint Petersburg Russian Federation 194156
339 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 191119
340 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 194354
341 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 197110
342 Novo Nordisk Investigational Site Saratov Russian Federation 410039
343 Novo Nordisk Investigational Site Saratov Russian Federation 410053
344 Novo Nordisk Investigational Site St. Petersburg Russian Federation 194354
345 Novo Nordisk Investigational Site Tomsk Russian Federation 634050
346 Novo Nordisk Investigational Site Tumen Russian Federation 625023
347 Novo Nordisk Investigational Site Ulianovsk Russian Federation 432063
348 Novo Nordisk Investigational Site Yaroslavl Russian Federation 150062
349 Novo Nordisk Investigational Site Yoshkar-Ola Russian Federation 424004
350 Novo Nordisk Investigational Site Belgrade Serbia 11000
351 Novo Nordisk Investigational Site Kragujevac Serbia 34000
352 Novo Nordisk Investigational Site Nis Serbia 18000
353 Novo Nordisk Investigational Site Novi Sad Serbia 21000
354 Novo Nordisk Investigational Site Zajecar Serbia 19000
355 Novo Nordisk Investigational Site Bratislava Slovakia 831 01
356 Novo Nordisk Investigational Site Bratislava Slovakia 83103
357 Novo Nordisk Investigational Site Bratislava Slovakia 833 05
358 Novo Nordisk Investigational Site Kosice Slovakia 040 01
359 Novo Nordisk Investigational Site Kosice Slovakia 04022
360 Novo Nordisk Investigational Site Krompachy Slovakia 05342
361 Novo Nordisk Investigational Site Nitra Slovakia 949 01
362 Novo Nordisk Investigational Site Poprad Slovakia 05801
363 Novo Nordisk Investigational Site Prievidza Slovakia 97101
364 Novo Nordisk Investigational Site Rimavska Sobota Slovakia 97901
365 Novo Nordisk Investigational Site Roznava Slovakia 04801
366 Novo Nordisk Investigational Site Vrutky Slovakia 038 61
367 Novo Nordisk Investigational Site Benoni Gauteng South Africa 1501
368 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 1619
369 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 1818
370 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 1827
371 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 1829
372 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 2198
373 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0083
374 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0181
375 Novo Nordisk Investigational Site Berea KwaZulu-Natal South Africa 4091
376 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4092
377 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4170
378 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4450
379 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7925
380 Novo Nordisk Investigational Site Alcorcón Spain 28922
381 Novo Nordisk Investigational Site Antequera Spain 29200
382 Novo Nordisk Investigational Site Barcelona Spain 08003
383 Novo Nordisk Investigational Site Burela Spain 27880
384 Novo Nordisk Investigational Site Córdoba Spain 14004
385 Novo Nordisk Investigational Site La Coruña Spain 15006
386 Novo Nordisk Investigational Site Las Palmas de Gran Canaria Spain 35010
387 Novo Nordisk Investigational Site Málaga Spain 29006
388 Novo Nordisk Investigational Site Pozuelo de Alarcon Spain 28223
389 Novo Nordisk Investigational Site Sanlúcar de Barrameda Spain 11540
390 Novo Nordisk Investigational Site Santander Spain 39008
391 Novo Nordisk Investigational Site Santiago de Compostela Spain 15706
392 Novo Nordisk Investigational Site Sevilla Spain 41009
393 Novo Nordisk Investigational Site Changhua City Taiwan 500
394 Novo Nordisk Investigational Site Taichung City Taiwan 402
395 Novo Nordisk Investigational Site Taoyuan city Taiwan 333
396 Novo Nordisk Investigational Site Bangkoknoi, Bangkok Thailand 10700
397 Novo Nordisk Investigational Site Bangkok Thailand 10330
398 Novo Nordisk Investigational Site Bangkok Thailand 10400
399 Novo Nordisk Investigational Site Bangkok Thailand 10700
400 Novo Nordisk Investigational Site Chiang Mai Thailand 50200
401 Novo Nordisk Investigational Site Nakhon Ratchasima Thailand 30000
402 Novo Nordisk Investigational Site Adana Turkey 01000
403 Novo Nordisk Investigational Site Ankara Turkey 06010
404 Novo Nordisk Investigational Site Bursa Turkey 16310
405 Novo Nordisk Investigational Site Erzurum Turkey 25240
406 Novo Nordisk Investigational Site Eskisehir Turkey 26040
407 Novo Nordisk Investigational Site Hatay Turkey 31060
408 Novo Nordisk Investigational Site Istanbul Turkey 34096
409 Novo Nordisk Investigational Site Istanbul Turkey 34303
410 Novo Nordisk Investigational Site Istanbul Turkey 34722
411 Novo Nordisk Investigational Site Izmir Turkey 35340
412 Novo Nordisk Investigational Site Kayseri Turkey 38039
413 Novo Nordisk Investigational Site Sivas Turkey 58140
414 Novo Nordisk Investigational Site Trabzon Turkey 61080
415 Novo Nordisk Investigational Site Cherkasy Ukraine 18009
416 Novo Nordisk Investigational Site Chernivtsi Ukraine 58022
417 Novo Nordisk Investigational Site Dnipro Ukraine 49005
418 Novo Nordisk Investigational Site Kyiv Ukraine 03049
419 Novo Nordisk Investigational Site Kyiv Ukraine 04053
420 Novo Nordisk Investigational Site Lviv Ukraine 79010
421 Novo Nordisk Investigational Site Odesa Ukraine 65025
422 Novo Nordisk Investigational Site Poltava Ukraine 36039
423 Novo Nordisk Investigational Site Uzhhorod Ukraine 88000
424 Novo Nordisk Investigational Site Zhytomyr Ukraine 10002
425 Novo Nordisk Investigational Site Aberdeen United Kingdom AB25 2ZD
426 Novo Nordisk Investigational Site Addlestone United Kingdom KT15 2BH
427 Novo Nordisk Investigational Site Belfast United Kingdom BT12 6BA
428 Novo Nordisk Investigational Site Bradford-on-Avon United Kingdom BA15 1DQ
429 Novo Nordisk Investigational Site Bristol United Kingdom BS10 5NB
430 Novo Nordisk Investigational Site Cambridge United Kingdom CB2 0QQ
431 Novo Nordisk Investigational Site Chippenham United Kingdom SN15 1HP
432 Novo Nordisk Investigational Site Coventry United Kingdom CV2 2DX
433 Novo Nordisk Investigational Site Edinburgh United Kingdom EH4 2XU
434 Novo Nordisk Investigational Site Glasgow United Kingdom G31 2ER
435 Novo Nordisk Investigational Site Glasgow United Kingdom G51 4TF
436 Novo Nordisk Investigational Site Harrogate United Kingdom HG2 7SX
437 Novo Nordisk Investigational Site Hinckley United Kingdom LE10 2SE
438 Novo Nordisk Investigational Site Hull United Kingdom HU3 2JZ
439 Novo Nordisk Investigational Site London United Kingdom NW3 2QG
440 Novo Nordisk Investigational Site Manchester United Kingdom M8 5RB
441 Novo Nordisk Investigational Site Norfolk United Kingdom NR4 7UQ
442 Novo Nordisk Investigational Site Plymouth United Kingdom PL6 8DH
443 Novo Nordisk Investigational Site Redhill United Kingdom RH1 5RH
444 Novo Nordisk Investigational Site Soham United Kingdom CB7 5JD
445 Novo Nordisk Investigational Site Swansea United Kingdom SA2 8PP

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:
NCT03914326
Other Study ID Numbers:
  • EX9924-4473
  • 2018-003141-42
  • U1111-1218-5368
First Posted:
Apr 16, 2019
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022