SELECT: Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03574597
Collaborator
(none)
17,500
815
2
59.1
21.5
0.4

Study Details

Study Description

Brief Summary

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
17500 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:
SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Actual Study Start Date :
Oct 24, 2018
Anticipated Primary Completion Date :
Sep 28, 2023
Anticipated Study Completion Date :
Sep 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Semaglutide

Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

Drug: Semaglutide
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.

Placebo Comparator: Placebo (semaglutide)

Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

Drug: Placebo (semaglutide)
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.

Outcome Measures

Primary Outcome Measures

  1. Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke [0-59 months]

    Measured in months

Secondary Outcome Measures

  1. Time to CV death [0-59 months]

    Measured in months

  2. Time to all-cause death [0-59 months]

    Measured in months

  3. Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation [0-59 months]

    Measured in months

  4. Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death [0-59 months]

    Measured in months

  5. Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke [0-59 months]

    Measured in months

  6. Time to first occurrence of non-fatal myocardial infarction [0-59 months]

    Measured in months

  7. Time to first occurrence of non-fatal stroke [0-59 months]

    Measured in months

  8. Time to first occurrence of coronary revascularisation [0-59 months]

    Measured in months

  9. Time to first occurrence of unstable angina requiring hospitalisation [0-59 months]

    Measured in months

  10. Time to first occurrence of heart failure hospitalisation or urgent heart failure visit [0-59 months]

    Measured in months

  11. Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%) [0-59 months]

    Measured in months

  12. Time to first occurrence of a 5-component composite nephropathy endpoint [0-59 months]

    Measured in months. A 5-component composite nephropathy endpoint consists of: onset of persistent macroalbuminuria (UACR above 300 mg/g), persistent 50% reduction in estimated Glomerular Filtration Rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR less than 15 ml/min/1.73m^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death.

  13. Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%) [0-59 months]

    Measured in months

  14. Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%) [0-59 months]

    Proportion of subjects

  15. Change in systolic blood pressure [Week 0, year 2]

    Measured in mm Hg

  16. Change in diastolic blood pressure [Week 0, year 2]

    Measured in mm Hg

  17. Change in pulse [Week 0, year 2]

    Measured in beats per minute

  18. Change in High sensitivity C-Reactive Protein (hsCRP) [Week 0, year 2]

    Measured in mg/dL

  19. Change in total cholesterol [Week 0, year 2]

    Measured in mg/dL

  20. Change in high density lipoprotein (HDL) cholesterol [Week 0, year 2]

    Measured in mg/dL

  21. Change in low density lipoprotein (LDL) cholesterol [Week 0, year 2]

    Measured in mg/dL

  22. Change in triglycerides [Week 0, year 2]

    Measured in mg/dL

  23. Change in body weight [Week 0, year 2]

    Measured in %

  24. Change in waist circumference [Week 0, year 2]

    Measured in cm

  25. Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire [Week 0, year 2]

    The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale [VAS]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.

  26. Change in total score weight related sign and symptom measure [Week 0, year 2]

    The weight related sign and symptom measure assesses the presence and bother associated with weight-related symptoms using a self-rated VAS. It is a tool to assess the multifaceted aspects of obesity on symptom experience in subjects with overweight or obesity.

  27. Change in haemoglobin A1c (HbA1c) [Screening (up to 3 weeks before randomisation at week 0), week 104]

    Measured in %

  28. Change in HbA1c [Screening (up to 3 weeks before randomisation at week 0), week 104]

    Measured in mmol/mol

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female, age greater than or equal to 45 years at the time of signing informed consent

  • Body mass index (BMI) greater than or equal to 27 kg/m^2

  • Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

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

  • HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening

  • History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)

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334 Novo Nordisk Investigational Site Svendborg Denmark 5700
335 Novo Nordisk Investigational Site Jyväskylä Finland 40620
336 Novo Nordisk Investigational Site Kuopio Finland 70100
337 Novo Nordisk Investigational Site Lahti Finland 15850
338 Novo Nordisk Investigational Site Oulu Finland 90220
339 Novo Nordisk Investigational Site Seinäjoki Finland 60220
340 Novo Nordisk Investigational Site Tampere Finland 33520
341 Novo Nordisk Investigational Site Turku Finland 20520
342 Novo Nordisk Investigational Site Besançon France 25030
343 Novo Nordisk Investigational Site Bondy France 93143
344 Novo Nordisk Investigational Site Corbeil Essonnes France 91106
345 Novo Nordisk Investigational Site DIJON cedex France 21079
346 Novo Nordisk Investigational Site La Tronche France 38700
347 Novo Nordisk Investigational Site Le Coudray France 28630
348 Novo Nordisk Investigational Site Narbonne France 11100
349 Novo Nordisk Investigational Site Nice France 06000
350 Novo Nordisk Investigational Site Paris Cedex 18 France 75877
351 Novo Nordisk Investigational Site Paris France 75013
352 Novo Nordisk Investigational Site Paris France 75015
353 Novo Nordisk Investigational Site Paris France 75475
354 Novo Nordisk Investigational Site Pessac France 33600
355 Novo Nordisk Investigational Site Reims France 51000
356 Novo Nordisk Investigational Site Saint Herblain France 44800
357 Novo Nordisk Investigational Site Strasbourg France 67091
358 Novo Nordisk Investigational Site Venissieux France 69200
359 Novo Nordisk Investigational Site Aachen Germany 52074
360 Novo Nordisk Investigational Site Bad Homburg Germany 61348
361 Novo Nordisk Investigational Site Berlin Germany 10117
362 Novo Nordisk Investigational Site Berlin Germany 10629
363 Novo Nordisk Investigational Site Berlin Germany 12627
364 Novo Nordisk Investigational Site Bochum Germany 44787
365 Novo Nordisk Investigational Site Dresden Germany 01069
366 Novo Nordisk Investigational Site Dresden Germany 01277
367 Novo Nordisk Investigational Site Elsterwerda Germany 04910
368 Novo Nordisk Investigational Site Essen Germany 45136
369 Novo Nordisk Investigational Site Frankfurt Germany 60313
370 Novo Nordisk Investigational Site Frankfurt Germany 60389
371 Novo Nordisk Investigational Site Friedrichsthal Germany 66299
372 Novo Nordisk Investigational Site Hamburg Germany 20253
373 Novo Nordisk Investigational Site Hamburg Germany 22607
374 Novo Nordisk Investigational Site Hannover Germany 30159
375 Novo Nordisk Investigational Site Karlsruhe Germany 76137
376 Novo Nordisk Investigational Site Kassel Germany 34121
377 Novo Nordisk Investigational Site Leipzig Germany 04103
378 Novo Nordisk Investigational Site Leipzig Germany 04107
379 Novo Nordisk Investigational Site Ludwigshafen Germany 67059
380 Novo Nordisk Investigational Site Lübeck Germany 23562
381 Novo Nordisk Investigational Site Oldenburg I. Holst Germany 23758
382 Novo Nordisk Investigational Site Pirna Germany 01796
383 Novo Nordisk Investigational Site Saint Ingbert-Oberwürzbach Germany 66386
384 Novo Nordisk Investigational Site Schkeuditz Germany 04435
385 Novo Nordisk Investigational Site Schwerin Germany 19055
386 Novo Nordisk Investigational Site Villingen-Schwenningen Germany 78048
387 Novo Nordisk Investigational Site Wangen Germany 88239
388 Novo Nordisk Investigational Site Wermsdorf Germany 04779
389 Novo Nordisk Investigational Site Witten Germany 58455
390 Novo Nordisk Investigational Site Athens Greece 17674
391 Novo Nordisk Investigational Site Athens Greece GR-11527
392 Novo Nordisk Investigational Site Athens Greece GR-11528
393 Novo Nordisk Investigational Site Athens Greece GR-14233
394 Novo Nordisk Investigational Site Athens Greece GR-15123
395 Novo Nordisk Investigational Site Athens Greece GR-15125
396 Novo Nordisk Investigational Site Chios Greece GR82100
397 Novo Nordisk Investigational Site Haidari-Athens Greece GR-12462
398 Novo Nordisk Investigational Site Ioannina Greece 45500
399 Novo Nordisk Investigational Site Lamia Greece GR35100
400 Novo Nordisk Investigational Site Larissa Greece GR-41110
401 Novo Nordisk Investigational Site Thessaloniki Greece GR-54636
402 Novo Nordisk Investigational Site Thessaloniki Greece GR-57001
403 Novo Nordisk Investigational Site Baja Hungary 6500
404 Novo Nordisk Investigational Site Budapest Hungary 1152
405 Novo Nordisk Investigational Site Gyöngyös Hungary 3200
406 Novo Nordisk Investigational Site Szeged Hungary H-6725
407 Novo Nordisk Investigational Site Szombathely Hungary H-9700
408 Novo Nordisk Investigational Site Zalaegerszeg Hungary 8900
409 Novo Nordisk Investigational Site Hyderabad Andhra Pradesh India 500020
410 Novo Nordisk Investigational Site Vijayawada Andhra Pradesh India 520008
411 Novo Nordisk Investigational Site Ahmedabad Gujarat India 380054
412 Novo Nordisk Investigational Site Ahmedabad Gujarat India 380060
413 Novo Nordisk Investigational Site Surat Gujarat India 395001
414 Novo Nordisk Investigational Site Surat Gujarat India 395002
415 Novo Nordisk Investigational Site Gurgaon Haryana India 122001
416 Novo Nordisk Investigational Site Bangalore Karnataka India 560069
417 Novo Nordisk Investigational Site Manipal Karnataka India 576104
418 Novo Nordisk Investigational Site Aurangabad Maharashtra India 431005
419 Novo Nordisk Investigational Site Mumbai Maharashtra India 400012
420 Novo Nordisk Investigational Site Mumbai Maharashtra India 400022
421 Novo Nordisk Investigational Site Mumbai Maharashtra India 400050
422 Novo Nordisk Investigational Site Nagpur Maharashtra India 440010
423 Novo Nordisk Investigational Site Nagpur Maharashtra India 440012
424 Novo Nordisk Investigational Site Nashik Maharashtra India 422005
425 Novo Nordisk Investigational Site Pune Maharashtra India 411001
426 Novo Nordisk Investigational Site Pune Maharashtra India 411004
427 Novo Nordisk Investigational Site Delhi New Delhi India 110002
428 Novo Nordisk Investigational Site New Dehli New Delhi India 110029
429 Novo Nordisk Investigational Site Amritsar Punjab India 143004
430 Novo Nordisk Investigational Site Bikaner Rajasthan India 334003
431 Novo Nordisk Investigational Site Chennai Tamil Nadu India 600037
432 Novo Nordisk Investigational Site Coimbatore Tamil Nadu India 641037
433 Novo Nordisk Investigational Site Vellore Tamil Nadu India 632004
434 Novo Nordisk Investigational Site Hyderbad Telengana India 500 012
435 Novo Nordisk Investigational Site Lucknow Uttar Pradesh India 226003
436 Novo Nordisk Investigational Site Kolkata West Bengal India 700027
437 Novo Nordisk Investigational Site Bangalore India 560 099
438 Novo Nordisk Investigational Site Bangalore India 560034
439 Novo Nordisk Investigational Site Ludhiana India 141001
440 Novo Nordisk Investigational Site New Delhi India 110005
441 Novo Nordisk Investigational Site New Delhi India 110060
442 Novo Nordisk Investigational Site New Delhi India 110062
443 Novo Nordisk Investigational Site Dublin Ireland A96 D628
444 Novo Nordisk Investigational Site Dublin Ireland D04 T6F4
445 Novo Nordisk Investigational Site Dublin Ireland D09 V2N0
446 Novo Nordisk Investigational Site Dublin Ireland D24NR0A
447 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 15
448 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 4
449 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 7
450 Novo Nordisk Investigational Site Galway Ireland H91 YR71
451 Novo Nordisk Investigational Site Mallow Ireland P51Y8EC
452 Novo Nordisk Investigational Site Beer Sheva Israel 84101
453 Novo Nordisk Investigational Site Haifa Israel 31096
454 Novo Nordisk Investigational Site Jerusalem Israel 91120
455 Novo Nordisk Investigational Site Kfar Saba Israel 44281
456 Novo Nordisk Investigational Site Nahariya Israel 22100
457 Novo Nordisk Investigational Site Petah-Tikva Israel 49372
458 Novo Nordisk Investigational Site Rehovot Israel 76100
459 Novo Nordisk Investigational Site Tel Aviv Israel 6423906
460 Novo Nordisk Investigational Site Tel Hashomer Israel 52621
461 Novo Nordisk Investigational Site Tel Hashomer Israel 5265601
462 Novo Nordisk Investigational Site Tel-Aviv Israel 64239
463 Novo Nordisk Investigational Site Bergamo Italy 24127
464 Novo Nordisk Investigational Site Bologna Italy 40138
465 Novo Nordisk Investigational Site Catania Italy 95122
466 Novo Nordisk Investigational Site Chieti Scalo Italy 66100
467 Novo Nordisk Investigational Site Como Italy 22042
468 Novo Nordisk Investigational Site Cona - Ferrara Italy 44124
469 Novo Nordisk Investigational Site Firenze Italy 50134
470 Novo Nordisk Investigational Site Genova Italy 16132
471 Novo Nordisk Investigational Site Latina Italy 04100
472 Novo Nordisk Investigational Site Napoli Italy 80131
473 Novo Nordisk Investigational Site Padova Italy 35128
474 Novo Nordisk Investigational Site Palermo Italy 90127
475 Novo Nordisk Investigational Site Pavia Italy 27100
476 Novo Nordisk Investigational Site Pisa Italy 56124
477 Novo Nordisk Investigational Site Roma Italy 00128
478 Novo Nordisk Investigational Site Roma Italy 00133
479 Novo Nordisk Investigational Site Rome Italy 00168
480 Novo Nordisk Investigational Site Rozzano (MI) Italy 20089
481 Novo Nordisk Investigational Site San Donato Milanese (MI) Italy 20097
482 Novo Nordisk Investigational Site Savigliano (CN) Italy 12038
483 Novo Nordisk Investigational Site Sesto San Giovanni (MI) Italy 20099
484 Novo Nordisk Investigational Site Siena Italy 53100
485 Novo Nordisk Investigational Site Torino Italy 10126
486 Novo Nordisk Investigational Site Adachi-ku, Tokyo Japan 123-0845
487 Novo Nordisk Investigational Site Asahikawa, Hokkaido Japan 078-8237
488 Novo Nordisk Investigational Site Bunkyo-ku, Tokyo Japan 113-8655
489 Novo Nordisk Investigational Site Chiba Japan 271-0077
490 Novo Nordisk Investigational Site Chikushino-shi, Fukuoka Japan 818-8516
491 Novo Nordisk Investigational Site Ehime Japan 790-0024
492 Novo Nordisk Investigational Site Funabashi-shi, Chiba Japan 274-8503
493 Novo Nordisk Investigational Site Gifu-city, Gifu Japan 500-8384
494 Novo Nordisk Investigational Site Hirakata-shi, Osaka Japan 573-0153
495 Novo Nordisk Investigational Site Hiroshima-shi, Hiroshima Japan 732-0057
496 Novo Nordisk Investigational Site Kagoshima-shi, Kagoshima Japan 892-0828
497 Novo Nordisk Investigational Site Kanagawa Japan 235-0045
498 Novo Nordisk Investigational Site Kasugai-shi, Aichi Japan 486-8510
499 Novo Nordisk Investigational Site Kawaguchi-shi, Saitama Japan 332-0012
500 Novo Nordisk Investigational Site Kitakyushu-shi, Fukuoka Japan 805-8508
501 Novo Nordisk Investigational Site Kochi-shi, Kochi Japan 780-8522
502 Novo Nordisk Investigational Site Kumamoto-shi, Kumamoto Japan 861-4193
503 Novo Nordisk Investigational Site Kyoto-shi, Kyoto Japan 600-8558
504 Novo Nordisk Investigational Site Kyoto-shi,Kyoto Japan 601-1495
505 Novo Nordisk Investigational Site Kyoto Japan 611-0041
506 Novo Nordisk Investigational Site Matsuyama-shi, Ehime Japan 790-0062
507 Novo Nordisk Investigational Site Miyagi Japan 983-0039
508 Novo Nordisk Investigational Site Moriyama-shi, Shiga Japan 524-8524
509 Novo Nordisk Investigational Site Nagoya-shi, Aichi Japan 454-8502
510 Novo Nordisk Investigational Site Naha-shi, Okinawa Japan 902-8511
511 Novo Nordisk Investigational Site Okawa-shi, Fukuoka Japan 831-0016
512 Novo Nordisk Investigational Site Okayama-shi, Okayama Japan 701-1192
513 Novo Nordisk Investigational Site Osaka-city, Osaka Japan 530-0001
514 Novo Nordisk Investigational Site Osaka Japan 569-1045
515 Novo Nordisk Investigational Site Saga-shi, Saga Japan 849-8501
516 Novo Nordisk Investigational Site Sapporo-shi, Hokkaido Japan 004-0004
517 Novo Nordisk Investigational Site Sapporo-shi, Hokkaido Japan 062-0003
518 Novo Nordisk Investigational Site Sapporo-shi, Hokkaido Japan 064-8570
519 Novo Nordisk Investigational Site Sendai-shi, Miyagi Japan 980-0873
520 Novo Nordisk Investigational Site Shinjuku-ku, Tokyo Japan 162-8655
521 Novo Nordisk Investigational Site Takamatsu-shi, Kagawa Japan 760-0073
522 Novo Nordisk Investigational Site Takamatsu-shi, Kagawa Japan 760-8557
523 Novo Nordisk Investigational Site Takasaki-shi, Gunma Japan 370-3513
524 Novo Nordisk Investigational Site Tokorozawa-shi, Saitama Japan 356-1142
525 Novo Nordisk Investigational Site Tokorozawa-shi,Saitama Japan 359-1141
526 Novo Nordisk Investigational Site Tokyo Japan 103-0027
527 Novo Nordisk Investigational Site Tokyo Japan 104-0031
528 Novo Nordisk Investigational Site Tokyo Japan 140-8522
529 Novo Nordisk Investigational Site Tokyo Japan 192-0918
530 Novo Nordisk Investigational Site Wako-city, Saitama Japan 351-0102
531 Novo Nordisk Investigational Site Yanagawa-shi, Fukuoka Japan 832-0059
532 Novo Nordisk Investigational Site Yokosuka-shi, Kanagawa Japan 238-856
533 Novo Nordisk Investigational Site Daugavpils Latvia LV5401
534 Novo Nordisk Investigational Site Liepaja Latvia LV-3414
535 Novo Nordisk Investigational Site Ogre Latvia LV-5001
536 Novo Nordisk Investigational Site Riga Latvia LV-1002
537 Novo Nordisk Investigational Site Riga Latvia LV-1011
538 Novo Nordisk Investigational Site Riga Latvia LV1011
539 Novo Nordisk Investigational Site Riga Latvia LV1012
540 Novo Nordisk Investigational Site Ventspils Latvia LV3601
541 Novo Nordisk Investigational Site Alor Gajah Malaysia 78300
542 Novo Nordisk Investigational Site Alor Setar Malaysia 05460
543 Novo Nordisk Investigational Site Kota Bharu, Kelantan Malaysia 16150
544 Novo Nordisk Investigational Site Kota Bharu Malaysia 15586
545 Novo Nordisk Investigational Site Kota Samarahan Malaysia 94300
546 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 50400
547 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 59100
548 Novo Nordisk Investigational Site Kuantan Malaysia 25100
549 Novo Nordisk Investigational Site Putrajaya Malaysia 62250
550 Novo Nordisk Investigational Site Sabah Malaysia 88300
551 Novo Nordisk Investigational Site Seri Manjung Malaysia 32040
552 Novo Nordisk Investigational Site Sungai Buloh Malaysia 47000
553 Novo Nordisk Investigational Site Torreon Coahuila Mexico 27000
554 Novo Nordisk Investigational Site Guadalajara Jalisco Mexico 44670
555 Novo Nordisk Investigational Site Ciudad de Mexico México, D.F. Mexico 03100
556 Novo Nordisk Investigational Site Ciudad de Mexico México, D.F. Mexico 14080
557 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64460
558 Novo Nordisk Investigational Site San Luis Potosí San Luis Potosi Mexico 78200
559 Novo Nordisk Investigational Site Culiacán Sinaloa Mexico 80230
560 Novo Nordisk Investigational Site Aguascalientes Mexico 20230
561 Novo Nordisk Investigational Site Durango Mexico 34000
562 Novo Nordisk Investigational Site Apeldoorn Netherlands 7334 DZ
563 Novo Nordisk Investigational Site Breda Netherlands 4818 CK
564 Novo Nordisk Investigational Site Deventer Netherlands 7416 SE
565 Novo Nordisk Investigational Site Groningen Netherlands 9713 GZ
566 Novo Nordisk Investigational Site Leeuwarden Netherlands 8934 AD
567 Novo Nordisk Investigational Site Leiderdorp Netherlands 2353 GA
568 Novo Nordisk Investigational Site Roosendaal Netherlands 4708 AE
569 Novo Nordisk Investigational Site Rotterdam Netherlands 3045 PM
570 Novo Nordisk Investigational Site Sneek Netherlands 8601 ZR
571 Novo Nordisk Investigational Site Tiel Netherlands 4002 WP
572 Novo Nordisk Investigational Site Bergen Norway 5021
573 Novo Nordisk Investigational Site Hamar Norway 2317
574 Novo Nordisk Investigational Site Lillehammer Norway 2609
575 Novo Nordisk Investigational Site Nordbyhagen Norway 1474
576 Novo Nordisk Investigational Site Oslo Norway 0372
577 Novo Nordisk Investigational Site Oslo Norway 0450
578 Novo Nordisk Investigational Site Oslo Norway 0586
579 Novo Nordisk Investigational Site Tønsberg Norway 3117
580 Novo Nordisk Investigational Site Ålesund Norway 6017
581 Novo Nordisk Investigational Site Bialystok Poland 15-281
582 Novo Nordisk Investigational Site Bialystok Poland 15-481
583 Novo Nordisk Investigational Site Gdansk Poland 80-286
584 Novo Nordisk Investigational Site Gdansk Poland 80-546
585 Novo Nordisk Investigational Site Gdynia Poland 81-338
586 Novo Nordisk Investigational Site Krakow Poland 30-033
587 Novo Nordisk Investigational Site Krakow Poland 31-271
588 Novo Nordisk Investigational Site Lodz Poland 90-242
589 Novo Nordisk Investigational Site Lomza Poland 18-404
590 Novo Nordisk Investigational Site Lowicz Poland 99-400
591 Novo Nordisk Investigational Site Lublin Poland 20-044
592 Novo Nordisk Investigational Site Poznan Poland 60-589
593 Novo Nordisk Investigational Site Poznan Poland 61-485
594 Novo Nordisk Investigational Site Pulawy Poland 24-100
595 Novo Nordisk Investigational Site Siedlce Poland 08-110
596 Novo Nordisk Investigational Site Skierniewice Poland 96-100
597 Novo Nordisk Investigational Site Szczecin Poland 71-531
598 Novo Nordisk Investigational Site Warsaw Poland 02-793
599 Novo Nordisk Investigational Site Warszawa Poland 00-001
600 Novo Nordisk Investigational Site Warszawa Poland 02-507
601 Novo Nordisk Investigational Site Zamosc Poland 22-400
602 Novo Nordisk Investigational Site Almada Portugal 2805-267
603 Novo Nordisk Investigational Site Coimbra Portugal 3000-561
604 Novo Nordisk Investigational Site Lisboa Portugal 1500-650
605 Novo Nordisk Investigational Site Lisboa Portugal 1649-035
606 Novo Nordisk Investigational Site Matosinhos Portugal 4464-513
607 Novo Nordisk Investigational Site Porto Portugal 4200-319
608 Novo Nordisk Investigational Site Trujillo Alto Puerto Rico 00976
609 Novo Nordisk Investigational Site Oradea Bihor Romania 410025
610 Novo Nordisk Investigational Site Oradea Bihor Romania 410151
611 Novo Nordisk Investigational Site Clarasi Calaras Romania 910103
612 Novo Nordisk Investigational Site Cluj Napoca Cluj Romania 400349
613 Novo Nordisk Investigational Site Craiova Dolj Romania 200515
614 Novo Nordisk Investigational Site Baia Mare Maramures Romania 430222
615 Novo Nordisk Investigational Site Targu Mures Mures Romania 540142
616 Novo Nordisk Investigational Site Timisoara Timis Romania 300736
617 Novo Nordisk Investigational Site Bacau Romania 600281
618 Novo Nordisk Investigational Site Brasov Romania 500283
619 Novo Nordisk Investigational Site Bucharest Romania 010507
620 Novo Nordisk Investigational Site Bucharest Romania 010825
621 Novo Nordisk Investigational Site Bucharest Romania 011025
622 Novo Nordisk Investigational Site Bucharest Romania 031818
623 Novo Nordisk Investigational Site Bucharest Romania 13682
624 Novo Nordisk Investigational Site Bucuresti Romania 011863
625 Novo Nordisk Investigational Site Buzau Romania 120203
626 Novo Nordisk Investigational Site Deva Romania 330084
627 Novo Nordisk Investigational Site Galati Romania 800098
628 Novo Nordisk Investigational Site Galati Romania 800291
629 Novo Nordisk Investigational Site Iasi Romania 700469
630 Novo Nordisk Investigational Site Iasi Romania 700547
631 Novo Nordisk Investigational Site Iasi Romania 700687
632 Novo Nordisk Investigational Site Pascani Romania 700502
633 Novo Nordisk Investigational Site Ploiesti Romania 100561
634 Novo Nordisk Investigational Site Satu Mare Romania 440055
635 Novo Nordisk Investigational Site Sibiu Romania 550371
636 Novo Nordisk Investigational Site Suceava Romania 720059
637 Novo Nordisk Investigational Site Arkhangelsk Russian Federation 163001
638 Novo Nordisk Investigational Site Barnaul Russian Federation 656024
639 Novo Nordisk Investigational Site Barnaul Russian Federation 656045
640 Novo Nordisk Investigational Site Barnaul Russian Federation 656055
641 Novo Nordisk Investigational Site Belgorod Russian Federation 308007
642 Novo Nordisk Investigational Site Ekaterinburg Russian Federation 620026
643 Novo Nordisk Investigational Site Ivanovo Russian Federation 153012
644 Novo Nordisk Investigational Site Kazan Russian Federation 420010
645 Novo Nordisk Investigational Site Kemerovo Russian Federation 650002
646 Novo Nordisk Investigational Site Moscow Russian Federation 109369
647 Novo Nordisk Investigational Site Moscow Russian Federation 111539
648 Novo Nordisk Investigational Site Moscow Russian Federation 117292
649 Novo Nordisk Investigational Site Moscow Russian Federation 119991
650 Novo Nordisk Investigational Site Moscow Russian Federation 121552
651 Novo Nordisk Investigational Site Moscow Russian Federation 123182
652 Novo Nordisk Investigational Site Moscow Russian Federation 127486
653 Novo Nordisk Investigational Site Moscow Russian Federation 129128
654 Novo Nordisk Investigational Site Moscow Russian Federation 129327
655 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630005
656 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630099
657 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630117
658 Novo Nordisk Investigational Site Orenburg Russian Federation 460018
659 Novo Nordisk Investigational Site Penza Russian Federation 440026
660 Novo Nordisk Investigational Site Rostov-on-Don Russian Federation 344068
661 Novo Nordisk Investigational Site Saint Petersburg Russian Federation 192283
662 Novo Nordisk Investigational Site Saint-Petersburg, Pushkin Russian Federation 196601
663 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 190013
664 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 190121
665 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 191119
666 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 191186
667 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 194156
668 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 194358
669 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 197022
670 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 197762
671 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 199226
672 Novo Nordisk Investigational Site Samara Russian Federation 443070
673 Novo Nordisk Investigational Site Sochi Russian Federation 354057
674 Novo Nordisk Investigational Site St. Petersburg Russian Federation 194354
675 Novo Nordisk Investigational Site Syktyvkar Russian Federation 167981
676 Novo Nordisk Investigational Site Tomsk Russian Federation 634012
677 Novo Nordisk Investigational Site Tomsk Russian Federation 634041
678 Novo Nordisk Investigational Site Tomsk Russian Federation 634050
679 Novo Nordisk Investigational Site Tumen Russian Federation 625023
680 Novo Nordisk Investigational Site Tver Russian Federation 170036
681 Novo Nordisk Investigational Site Ulianovsk Russian Federation 432063
682 Novo Nordisk Investigational Site Voronezh Russian Federation 394018
683 Novo Nordisk Investigational Site Yaroslavl Russian Federation 150003
684 Novo Nordisk Investigational Site Belgrade Serbia 11000
685 Novo Nordisk Investigational Site Belgrade Serbia 11080
686 Novo Nordisk Investigational Site Novi Sad Serbia 21000
687 Novo Nordisk Investigational Site Port Elizabeth Eastern Cape South Africa 6001
688 Novo Nordisk Investigational Site Bloemfontein Free State South Africa 9301
689 Novo Nordisk Investigational Site Alberton Gauteng South Africa 1450
690 Novo Nordisk Investigational Site Centurion Gauteng South Africa 0157
691 Novo Nordisk Investigational Site Germiston Gauteng South Africa 1401
692 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 2013
693 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 2157
694 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 2193
695 Novo Nordisk Investigational Site Lenasia Gauteng South Africa 1827
696 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0183
697 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0184
698 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0186
699 Novo Nordisk Investigational Site Roodepoort Gauteng South Africa 1724
700 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4091
701 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7130
702 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7405
703 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7500
704 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7700
705 Novo Nordisk Investigational Site Kuilsriver Western Cape South Africa 7580
706 Novo Nordisk Investigational Site Paarl Western Cape South Africa 7646
707 Novo Nordisk Investigational Site Worcester Western Cape South Africa 6850
708 Novo Nordisk Investigational Site Almeria Spain 04009
709 Novo Nordisk Investigational Site La Coruña Spain 15006
710 Novo Nordisk Investigational Site Madrid Spain 28009
711 Novo Nordisk Investigational Site Madrid Spain 28034
712 Novo Nordisk Investigational Site Madrid Spain 28046
713 Novo Nordisk Investigational Site Málaga Spain 29006
714 Novo Nordisk Investigational Site Palma de Mallorca Spain 07198
715 Novo Nordisk Investigational Site Sevilla Spain 41003
716 Novo Nordisk Investigational Site Sevilla Spain 41009
717 Novo Nordisk Investigational Site Sevilla Spain 41010
718 Novo Nordisk Investigational Site Valencia Spain 46026
719 Novo Nordisk Investigational Site Göteborg Sweden 413 45
720 Novo Nordisk Investigational Site Kristianstad Sweden 291 85
721 Novo Nordisk Investigational Site Lund Sweden 222 21
722 Novo Nordisk Investigational Site Stockholm Sweden 171 64
723 Novo Nordisk Investigational Site Örebro Sweden 701 85
724 Novo Nordisk Investigational Site Östersund Sweden 831 83
725 Novo Nordisk Investigational Site Hsinchu City Taiwan 300
726 Novo Nordisk Investigational Site Kaohsiung City Taiwan 82445
727 Novo Nordisk Investigational Site New Taipei City Taiwan 25160
728 Novo Nordisk Investigational Site Taipei Taiwan 100
729 Novo Nordisk Investigational Site Taoyuan City Taiwan 333
730 Novo Nordisk Investigational Site Bangkok Thailand 10330
731 Novo Nordisk Investigational Site Bangkok Thailand 10400
732 Novo Nordisk Investigational Site Bangkok Thailand 10700
733 Novo Nordisk Investigational Site Chiang Mai Thailand 50200
734 Novo Nordisk Investigational Site Khon kaen Thailand 40002
735 Novo Nordisk Investigational Site Klong Luang, Pathumthani Thailand 12120
736 Novo Nordisk Investigational Site Adana Turkey 01250
737 Novo Nordisk Investigational Site Adana Turkey 01330
738 Novo Nordisk Investigational Site Ankara Turkey 06010
739 Novo Nordisk Investigational Site Ankara Turkey 06100
740 Novo Nordisk Investigational Site Antalya Turkey 07058
741 Novo Nordisk Investigational Site Aydin Turkey 09010
742 Novo Nordisk Investigational Site Eskisehir Turkey 26040
743 Novo Nordisk Investigational Site Gaziantep Turkey 27070
744 Novo Nordisk Investigational Site Istanbul Turkey 34010
745 Novo Nordisk Investigational Site Istanbul Turkey 34098
746 Novo Nordisk Investigational Site Istanbul Turkey 34371
747 Novo Nordisk Investigational Site Istanbul Turkey 34390
748 Novo Nordisk Investigational Site Istanbul Turkey 34400
749 Novo Nordisk Investigational Site Istanbul Turkey 34752
750 Novo Nordisk Investigational Site Istanbul Turkey 34760
751 Novo Nordisk Investigational Site Istanbul Turkey 34899
752 Novo Nordisk Investigational Site Izmir Turkey 35100
753 Novo Nordisk Investigational Site Izmir Turkey 35180
754 Novo Nordisk Investigational Site Izmir Turkey 35340
755 Novo Nordisk Investigational Site Kayseri Turkey 38039
756 Novo Nordisk Investigational Site Mersin Turkey 33343
757 Novo Nordisk Investigational Site Sivas Turkey 58140
758 Novo Nordisk Investigational Site Chernivtsi Ukraine 58000
759 Novo Nordisk Investigational Site Kharkiv Ukraine 61002
760 Novo Nordisk Investigational Site Kharkiv Ukraine 61039
761 Novo Nordisk Investigational Site Kyiv Ukraine 01023
762 Novo Nordisk Investigational Site Kyiv Ukraine 01135
763 Novo Nordisk Investigational Site Kyiv Ukraine 02091
764 Novo Nordisk Investigational Site Kyiv Ukraine 02660
765 Novo Nordisk Investigational Site Kyiv Ukraine 03049
766 Novo Nordisk Investigational Site Kyiv Ukraine 03151
767 Novo Nordisk Investigational Site Kyiv Ukraine 04053
768 Novo Nordisk Investigational Site Lviv Ukraine 79059
769 Novo Nordisk Investigational Site Odesa Ukraine 65025
770 Novo Nordisk Investigational Site Odesa Ukraine 65059
771 Novo Nordisk Investigational Site Vinnytsia Ukraine 21000
772 Novo Nordisk Investigational Site Vinnytsia Ukraine 21018
773 Novo Nordisk Investigational Site Zhytomyr Ukraine 10002
774 Novo Nordisk Investigational Site Addlestone United Kingdom KT15 2BH
775 Novo Nordisk Investigational Site Airdrie United Kingdom ML6 0JS
776 Novo Nordisk Investigational Site Antrim United Kingdom BT42 2RL
777 Novo Nordisk Investigational Site Axbridge United Kingdom BS26 2BJ
778 Novo Nordisk Investigational Site Basingstoke United Kingdom RG24 9GT
779 Novo Nordisk Investigational Site Bexhill-on-Sea United Kingdom TN40 1JJ
780 Novo Nordisk Investigational Site Birmingham United Kingdom B9 5SS
781 Novo Nordisk Investigational Site Blackpool United Kingdom FY3 7EN
782 Novo Nordisk Investigational Site Bollington United Kingdom SK10 5JH
783 Novo Nordisk Investigational Site Bradford-on-Avon United Kingdom BA15 1DQ
784 Novo Nordisk Investigational Site Bristol United Kingdom BS10 5NB
785 Novo Nordisk Investigational Site Cardiff United Kingdom CF5 4AD
786 Novo Nordisk Investigational Site Chertsey United Kingdom KT16 0PZ
787 Novo Nordisk Investigational Site Chester United Kingdom CH2 1UL
788 Novo Nordisk Investigational Site Coventry United Kingdom CV2 2DX
789 Novo Nordisk Investigational Site Denmark Hill, London United Kingdom SE5 9RS
790 Novo Nordisk Investigational Site Dundee United Kingdom DD1 9SY
791 Novo Nordisk Investigational Site Exeter United Kingdom EX2 5DW
792 Novo Nordisk Investigational Site Harrogate, North Yorkshire United Kingdom HG2 7SX
793 Novo Nordisk Investigational Site Harrow United Kingdom HA1 3UJ
794 Novo Nordisk Investigational Site High Wycombe United Kingdom HP11 2TT
795 Novo Nordisk Investigational Site Hull United Kingdom HU3 2JZ
796 Novo Nordisk Investigational Site Leicester United Kingdom LE3 9QP
797 Novo Nordisk Investigational Site Lincoln United Kingdom LN2 5QY
798 Novo Nordisk Investigational Site Liverpool United Kingdom L9 7AL
799 Novo Nordisk Investigational Site London United Kingdom SE1 9RT
800 Novo Nordisk Investigational Site London United Kingdom W12 0NN
801 Novo Nordisk Investigational Site Manchester United Kingdom M8 5RB
802 Novo Nordisk Investigational Site Middlesbrough United Kingdom TS4 3BW
803 Novo Nordisk Investigational Site Plymouth United Kingdom PL6 8DH
804 Novo Nordisk Investigational Site Rhyl United Kingdom LL18 1DA
805 Novo Nordisk Investigational Site Rotherham United Kingdom S65 1DA
806 Novo Nordisk Investigational Site Sandbach United Kingdom CW11 1EQ
807 Novo Nordisk Investigational Site Somerset United Kingdom BA21 4AT
808 Novo Nordisk Investigational Site Southampton United Kingdom SO30 3JB
809 Novo Nordisk Investigational Site Stevenage United Kingdom SG1 4AB
810 Novo Nordisk Investigational Site Sunderland United Kingdom SR4 7TP
811 Novo Nordisk Investigational Site Taunton United Kingdom TA1 5DA
812 Novo Nordisk Investigational Site Torquay United Kingdom TQ2 7AA
813 Novo Nordisk Investigational Site Truro United Kingdom TR1 3LJ
814 Novo Nordisk Investigational Site West Sussex United Kingdom PO19 6SE
815 Novo Nordisk Investigational Site Wishaw United Kingdom ML2 0DP

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:
NCT03574597
Other Study ID Numbers:
  • EX9536-4388
  • 2017-003380-35
  • U1111-1200-5564
First Posted:
Jul 2, 2018
Last Update Posted:
Mar 21, 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 21, 2022