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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914326
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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
Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 17, 2019
Estimated Primary Completion Date : July 29, 2024
Estimated Study Completion Date : July 29, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

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




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: From randomisation (week 0) to end-of-trial (up to 61 months or more) ]
    Months

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

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

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

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

  20. Time to first occurrence of chronic limb ischemia [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From randomisation (week 0) to 2 years ]
    Percent points

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

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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):

    a) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914326


Contacts
Layout table for location contacts
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, Alabama
Novo Nordisk Investigational Site Recruiting
Montgomery, Alabama, United States, 36109
United States, Arkansas
Novo Nordisk Investigational Site Recruiting
Little Rock, Arkansas, United States, 72211
Novo Nordisk Investigational Site Recruiting
Searcy, Arkansas, United States, 72143
United States, California
Novo Nordisk Investigational Site Recruiting
Fresno, California, United States, 93721-1443
Novo Nordisk Investigational Site Recruiting
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site Recruiting
La Mesa, California, United States, 91942
Novo Nordisk Investigational Site Recruiting
Lancaster, California, United States, 93534
Novo Nordisk Investigational Site Recruiting
Los Alamitos, California, United States, 90720
Novo Nordisk Investigational Site Not yet recruiting
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site Recruiting
Monterey, California, United States, 93940
Novo Nordisk Investigational Site Recruiting
Palm Springs, California, United States, 92262
Novo Nordisk Investigational Site Recruiting
San Diego, California, United States, 92111
Novo Nordisk Investigational Site Recruiting
Torrance, California, United States, 90502
Novo Nordisk Investigational Site Recruiting
Ventura, California, United States, 93003
United States, Colorado
Novo Nordisk Investigational Site Recruiting
Aurora, Colorado, United States, 80045
Novo Nordisk Investigational Site Recruiting
Denver, Colorado, United States, 80246
Novo Nordisk Investigational Site Recruiting
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Investigational Site Recruiting
Boca Raton, Florida, United States, 33433
Novo Nordisk Investigational Site Recruiting
New Port Richey, Florida, United States, 34652
Novo Nordisk Investigational Site Recruiting
Orlando, Florida, United States, 32804
United States, Georgia
Novo Nordisk Investigational Site Recruiting
Atlanta, Georgia, United States, 30342
Novo Nordisk Investigational Site Recruiting
Lawrenceville, Georgia, United States, 30046
Novo Nordisk Investigational Site Recruiting
Roswell, Georgia, United States, 30076
United States, Hawaii
Novo Nordisk Investigational Site Recruiting
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Investigational Site Recruiting
Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
Novo Nordisk Investigational Site Recruiting
Gurnee, Illinois, United States, 60031
United States, Indiana
Novo Nordisk Investigational Site Recruiting
Franklin, Indiana, United States, 46131
Novo Nordisk Investigational Site Recruiting
Greenfield, Indiana, United States, 46140
Novo Nordisk Investigational Site Recruiting
Michigan City, Indiana, United States, 46360
Novo Nordisk Investigational Site Recruiting
Muncie, Indiana, United States, 47304
United States, Iowa
Novo Nordisk Investigational Site Recruiting
West Des Moines, Iowa, United States, 50265
United States, Kentucky
Novo Nordisk Investigational Site Recruiting
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site Recruiting
Louisville, Kentucky, United States, 40213
United States, Louisiana
Novo Nordisk Investigational Site Recruiting
New Orleans, Louisiana, United States, 70112
Novo Nordisk Investigational Site Recruiting
Slidell, Louisiana, United States, 70461-4231
United States, Michigan
Novo Nordisk Investigational Site Recruiting
Buckley, Michigan, United States, 49620
United States, Nebraska
Novo Nordisk Investigational Site Recruiting
Omaha, Nebraska, United States, 68114
Novo Nordisk Investigational Site Recruiting
Omaha, Nebraska, United States, 68198-3020
United States, Nevada
Novo Nordisk Investigational Site Recruiting
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Novo Nordisk Investigational Site Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Novo Nordisk Investigational Site Recruiting
Nashua, New Hampshire, United States, 03063
United States, New York
Novo Nordisk Investigational Site Recruiting
Albany, New York, United States, 12206
Novo Nordisk Investigational Site Recruiting
West Seneca, New York, United States, 14224
Novo Nordisk Investigational Site Recruiting
Westfield, New York, United States, 14787
United States, North Carolina
Novo Nordisk Investigational Site Recruiting
Asheville, North Carolina, United States, 28803
Novo Nordisk Investigational Site Recruiting
Burlington, North Carolina, United States, 27215
Novo Nordisk Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27517
Novo Nordisk Investigational Site Recruiting
Greenville, North Carolina, United States, 27834
Novo Nordisk Investigational Site Recruiting
New Bern, North Carolina, United States, 28562
Novo Nordisk Investigational Site Recruiting
Whiteville, North Carolina, United States, 28472
Novo Nordisk Investigational Site Recruiting
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Novo Nordisk Investigational Site Recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
Novo Nordisk Investigational Site Suspended
Marion, Ohio, United States, 43302
Novo Nordisk Investigational Site Recruiting
Maumee, Ohio, United States, 43537
Novo Nordisk Investigational Site Recruiting
Mentor, Ohio, United States, 44060
United States, Oklahoma
Novo Nordisk Investigational Site Recruiting
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Novo Nordisk Investigational Site Recruiting
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Investigational Site Recruiting
McMurray, Pennsylvania, United States, 15317
Novo Nordisk Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19114
Novo Nordisk Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
Novo Nordisk Investigational Site Recruiting
Murrells Inlet, South Carolina, United States, 29576
Novo Nordisk Investigational Site Recruiting
Myrtle Beach, South Carolina, United States, 29572
Novo Nordisk Investigational Site Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Investigational Site Suspended
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site Recruiting
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site Recruiting
Kingsport, Tennessee, United States, 37660
Novo Nordisk Investigational Site Recruiting
Nashville, Tennessee, United States, 37203
Novo Nordisk Investigational Site Recruiting
Nashville, Tennessee, United States, 37212
Novo Nordisk Investigational Site Recruiting
Tullahoma, Tennessee, United States, 37388
United States, Texas
Novo Nordisk Investigational Site Recruiting
Arlington, Texas, United States, 76012-4637
Novo Nordisk Investigational Site Recruiting
Austin, Texas, United States, 78705
Novo Nordisk Investigational Site Recruiting
Austin, Texas, United States, 78731
Novo Nordisk Investigational Site Recruiting
Austin, Texas, United States, 78749
Novo Nordisk Investigational Site Recruiting
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site Recruiting
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site Recruiting
Fort Worth, Texas, United States, 76132
Novo Nordisk Investigational Site Recruiting
Houston, Texas, United States, 77024
Novo Nordisk Investigational Site Recruiting
Houston, Texas, United States, 77061
Novo Nordisk Investigational Site Recruiting
Longview, Texas, United States, 75605
Novo Nordisk Investigational Site Recruiting
Midland, Texas, United States, 79707
Novo Nordisk Investigational Site Recruiting
Round Rock, Texas, United States, 78681
Novo Nordisk Investigational Site Recruiting
Sugar Land, Texas, United States, 77478
Novo Nordisk Investigational Site Recruiting
Waco, Texas, United States, 76710
United States, Vermont
Novo Nordisk Investigational Site Not yet recruiting
South Burlington, Vermont, United States, 05403
United States, Virginia
Novo Nordisk Investigational Site Recruiting
Richmond, Virginia, United States, 23219
Novo Nordisk Investigational Site Recruiting
Winchester, Virginia, United States, 22601-3834
United States, Wisconsin
Novo Nordisk Investigational Site Recruiting
Kenosha, Wisconsin, United States, 53144
Algeria
Novo Nordisk Investigational Site Not yet recruiting
Algiers, Algeria, 16000
Novo Nordisk Investigational Site Not yet recruiting
Constantine, Algeria, 25000
Novo Nordisk Investigational Site Not yet recruiting
Oran, Algeria, 31000
Novo Nordisk Investigational Site Not yet recruiting
Setif, Algeria, 19000
Argentina
Novo Nordisk Investigational Site Recruiting
Buenos Aires, Argentina, B1704ETD
Novo Nordisk Investigational Site Recruiting
Buenos Aires, Argentina, B6000BHA
Novo Nordisk Investigational Site Recruiting
Capital Federal, Argentina, C1056ABJ
Novo Nordisk Investigational Site Recruiting
Cordoba, Argentina, 5000
Novo Nordisk Investigational Site Recruiting
Córdoba, Argentina, 5008
Novo Nordisk Investigational Site Recruiting
Córdoba, Argentina, X5003DCE
Novo Nordisk Investigational Site Recruiting
Córdoba, Argentina, X5006IKK
Novo Nordisk Investigational Site Recruiting
Lanus Este, Argentina, B1824KAJ
Novo Nordisk Investigational Site Recruiting
Mar del Plata, Argentina, B7600FZN
Novo Nordisk Investigational Site Recruiting
Rosario, Santa Fe, Argentina, S2000CVB
Austria
Novo Nordisk Investigational Site Recruiting
Graz, Austria, 8036
Novo Nordisk Investigational Site Recruiting
Innsbruck, Austria, 6020
Novo Nordisk Investigational Site Recruiting
Saint Stefan, Austria, 8511
Novo Nordisk Investigational Site Recruiting
Vienna, Austria, 1160
Novo Nordisk Investigational Site Recruiting
Wien, Austria, 1130
Belgium
Novo Nordisk Investigational Site Recruiting
Bonheiden, Belgium, 2820
Novo Nordisk Investigational Site Recruiting
Edegem, Belgium, 2650
Novo Nordisk Investigational Site Recruiting
Gent, Belgium, 9000
Novo Nordisk Investigational Site Recruiting
Kortrijk, Belgium, 8500
Novo Nordisk Investigational Site Recruiting
Leuven, Belgium, 3000
Novo Nordisk Investigational Site Recruiting
Roeselare, Belgium, 8800
Brazil
Novo Nordisk Investigational Site Not yet recruiting
Curitiba, Parana, Brazil, 80030-480
Novo Nordisk Investigational Site Not yet recruiting
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Novo Nordisk Investigational Site Not yet recruiting
Campinas, Sao Paulo, Brazil, 13010-001
Novo Nordisk Investigational Site Not yet recruiting
Campinas, Sao Paulo, Brazil, 13060-080
Novo Nordisk Investigational Site Not yet recruiting
São Paulo, Sao Paulo, Brazil, 01228-000
Novo Nordisk Investigational Site Not yet recruiting
São Paulo, Sao Paulo, Brazil, 01228-200
Canada, Alberta
Novo Nordisk Investigational Site Recruiting
Calgary, Alberta, Canada, T2V 4J2
Canada, Nova Scotia
Novo Nordisk Investigational Site Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Novo Nordisk Investigational Site Recruiting
Barrie, Ontario, Canada, L4N 7L3
Novo Nordisk Investigational Site Recruiting
Brampton, Ontario, Canada, L6S 0C6
Novo Nordisk Investigational Site Recruiting
Brampton, Ontario, Canada, L6T 0G1
Novo Nordisk Investigational Site Recruiting
Concord, Ontario, Canada, L4K 4M2
Novo Nordisk Investigational Site Recruiting
Hamilton, Ontario, Canada, L8M 1K7
Novo Nordisk Investigational Site Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Novo Nordisk Investigational Site Not yet recruiting
Markham, Ontario, Canada, L3P 7P2
Novo Nordisk Investigational Site Recruiting
Sarnia, Ontario, Canada, N7T 4X3
Novo Nordisk Investigational Site Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Novo Nordisk Investigational Site Recruiting
Toronto, Ontario, Canada, M6G 1M2
Canada, Quebec
Novo Nordisk Investigational Site Recruiting
Mirabel, Quebec, Canada, J7J 2K8
Novo Nordisk Investigational Site Recruiting
Montreal, Quebec, Canada, H4A 3T2
China, Beijing
Novo Nordisk Investigational Site Not yet recruiting
Beijing, Beijing, China, 100044
China, Hebei
Novo Nordisk Investigational Site Not yet recruiting
Cangzhou, Hebei, China, 061000
China, Jiangsu
Novo Nordisk Investigational Site Not yet recruiting
Changzhou, Jiangsu, China, 213003
Novo Nordisk Investigational Site Not yet recruiting
Zhenjiang, Jiangsu, China, 212001
China, Shandong
Novo Nordisk Investigational Site Not yet recruiting
Jinan, Shandong, China, 250013
China, Shanghai
Novo Nordisk Investigational Site Not yet recruiting
Shanghai, Shanghai, China, 200240
Colombia
Novo Nordisk Investigational Site Recruiting
Barranquilla, Colombia, 80020
Novo Nordisk Investigational Site Recruiting
Bucaramanga, Colombia, 681004
Novo Nordisk Investigational Site Not yet recruiting
Cali, Colombia, 760032
Novo Nordisk Investigational Site Not yet recruiting
San Juan De Pasto, Colombia, 520002
Novo Nordisk Investigational Site Recruiting
Soledad, Colombia, 83001
Croatia
Novo Nordisk Investigational Site Recruiting
Krapinske Toplice, Croatia, 49217
Novo Nordisk Investigational Site Recruiting
Osijek, Croatia, 31 000
Novo Nordisk Investigational Site Suspended
Rijeka, Croatia, 51000
Novo Nordisk Investigational Site Recruiting
Split, Croatia, 21 000
Novo Nordisk Investigational Site Recruiting
Varazdin, Croatia, 42 000
Novo Nordisk Investigational Site Recruiting
Zadar, Croatia, 23000
Novo Nordisk Investigational Site Recruiting
Zagreb, Croatia, 10 000
Novo Nordisk Investigational Site Recruiting
Zagreb, Croatia, 10000
Novo Nordisk Investigational Site Not yet recruiting
Zagreb, Croatia, 10000
Czechia
Novo Nordisk Investigational Site Recruiting
Brno, Czechia, 656 91
Novo Nordisk Investigational Site Recruiting
Chrudim, Czechia, 53701
Novo Nordisk Investigational Site Recruiting
Hradec Kralove, Czechia, 500 05
Novo Nordisk Investigational Site Recruiting
Moravska Ostrava, Czechia, 70200
Novo Nordisk Investigational Site Recruiting
Ostrava, Czechia, 73000
Novo Nordisk Investigational Site Recruiting
Plzen, Czechia, 30166
Novo Nordisk Investigational Site Recruiting
Plzen, Czechia, 32600
Novo Nordisk Investigational Site Recruiting
Plzeň, Czechia, 301 00
Novo Nordisk Investigational Site Recruiting
Praha, Czechia, 14021
Denmark
Novo Nordisk Investigational Site Recruiting
Aarhus N, Denmark, 8200
Novo Nordisk Investigational Site Recruiting
Hillerød, Denmark, 3400
Novo Nordisk Investigational Site Recruiting
København, Denmark, 2400
Novo Nordisk Investigational Site Recruiting
Slagelse, Denmark, 4200
Novo Nordisk Investigational Site Recruiting
Svendborg, Denmark, 5700
France
Novo Nordisk Investigational Site Recruiting
Besançon cedex, France, 25030
Novo Nordisk Investigational Site Recruiting
DIJON cedex, France, 21079
Novo Nordisk Investigational Site Recruiting
Le Coudray, France, 28630
Novo Nordisk Investigational Site Not yet recruiting
Marseille, France, 13005
Novo Nordisk Investigational Site Recruiting
Paris, France, 75877
Novo Nordisk Investigational Site Not yet recruiting
Pessac, France, 33600
Novo Nordisk Investigational Site Recruiting
Strasbourg, France, 67098
Germany
Novo Nordisk Investigational Site Recruiting
Dresden, Germany, 01277
Novo Nordisk Investigational Site Recruiting
Dresden, Germany, 01307
Novo Nordisk Investigational Site Recruiting
Essen, Germany, 45219
Novo Nordisk Investigational Site Recruiting
Falkensee, Germany, 14612
Novo Nordisk Investigational Site Recruiting
Hamburg, Germany, 21073
Novo Nordisk Investigational Site Recruiting
Hamburg, Germany, 22041
Novo Nordisk Investigational Site Recruiting
Jerichow, Germany, 39319
Novo Nordisk Investigational Site Recruiting
Lingen, Germany, 49808
Novo Nordisk Investigational Site Recruiting
Ludwigshafen, Germany, 67059
Novo Nordisk Investigational Site Recruiting
Münster, Germany, 48145
Novo Nordisk Investigational Site Recruiting
Oldenburg I. Holst, Germany, 23758
Novo Nordisk Investigational Site Recruiting
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site Recruiting
Stuttgart, Germany, 70199
Novo Nordisk Investigational Site Recruiting
Witten, Germany, 58455
Hong Kong
Novo Nordisk Investigational Site Recruiting
Shatin, New Territories, Hong Kong
India
Novo Nordisk Investigational Site Recruiting
Hyderabad, Andhra Pradesh, India, 500003
Novo Nordisk Investigational Site Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Novo Nordisk Investigational Site Recruiting
Hyderabad, Andhra Pradesh, India, 500072
Novo Nordisk Investigational Site Recruiting
Ahmedabad, Gujarat, India, 380006
Novo Nordisk Investigational Site Not yet recruiting
Rohtak, Haryana, India, 124001
Novo Nordisk Investigational Site Recruiting
Bangalore, Karnataka, India, 560092
Novo Nordisk Investigational Site Not yet recruiting
Kozhikode, Kerala, India, 673017
Novo Nordisk Investigational Site Recruiting
Indore, Madhya Pradesh, India, 452010
Novo Nordisk Investigational Site Recruiting
Mumbai, Maharashtra, India, 400058
Novo Nordisk Investigational Site Recruiting
Pune, Maharashtra, India, 411021
Novo Nordisk Investigational Site Recruiting
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site Recruiting
Ludhiana, Punjab, India, 141008
Novo Nordisk Investigational Site Recruiting
Jaipur, Rajasthan, India, 302006
Novo Nordisk Investigational Site Recruiting
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site Recruiting
Coimbatore, Tamil Nadu, India, 641018
Novo Nordisk Investigational Site Recruiting
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site Recruiting
Ludhiana, India, 141001
Novo Nordisk Investigational Site Recruiting
Thriruvananthapuram, India, 695 032
Israel
Novo Nordisk Investigational Site Recruiting
Haifa, Israel, 31096
Novo Nordisk Investigational Site Recruiting
Jerusalem, Israel, 91120
Novo Nordisk Investigational Site Not yet recruiting
Jerusalem, Israel, 93106
Novo Nordisk Investigational Site Recruiting
Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site Recruiting
Nahariya, Israel, 22100
Novo Nordisk Investigational Site Recruiting
Petah-Tikva, Israel, 49100
Novo Nordisk Investigational Site Recruiting
Tel Hashomer, Israel, 52621
Novo Nordisk Investigational Site Recruiting
Tel-Aviv, Israel, 64239
Italy
Novo Nordisk Investigational Site Not yet recruiting
Bari, Italy, 70124
Novo Nordisk Investigational Site Recruiting
Catanzaro, Italy, 88100
Novo Nordisk Investigational Site Not yet recruiting
Chieti, Italy, 66100
Novo Nordisk Investigational Site Not yet recruiting
Lucca, Italy, 55100
Novo Nordisk Investigational Site Recruiting
Milano, Italy, 20132
Novo Nordisk Investigational Site Not yet recruiting
Milano, Italy, 20138
Novo Nordisk Investigational Site Not yet recruiting
Napoli, Italy, 80131
Novo Nordisk Investigational Site Recruiting
Palermo, Italy, 90129
Novo Nordisk Investigational Site Not yet recruiting
Perugia, Italy, 06156
Novo Nordisk Investigational Site Not yet recruiting
Roma, Italy, 00133
Novo Nordisk Investigational Site Recruiting
Roma, Italy, 00161
Japan
Novo Nordisk Investigational Site Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Novo Nordisk Investigational Site Recruiting
Chiba, Japan, 271-0077
Novo Nordisk Investigational Site Recruiting
Ehime, Japan, 790-0024
Novo Nordisk Investigational Site Recruiting
Fukui, Japan, 910-0846
Novo Nordisk Investigational Site Recruiting
Fukuoka, Japan, 816-0864
Novo Nordisk Investigational Site Recruiting
Ibaraki, Japan, 311-0113
Novo Nordisk Investigational Site Recruiting
Kumamoto, Japan, 862-0976
Novo Nordisk Investigational Site Not yet recruiting
Kyoto-shi, Kyoto, Japan, 606-8507
Novo Nordisk Investigational Site Recruiting
Kyoto, Japan, 611-0041
Novo Nordisk Investigational Site Recruiting
Miyagi, Japan, 983-0039
Novo Nordisk Investigational Site Recruiting
Miyazaki, Japan, 880-0034
Novo Nordisk Investigational Site Recruiting
Nagano, Japan, 390-8621
Novo Nordisk Investigational Site Recruiting
Osaka, Japan, 564-0013
Novo Nordisk Investigational Site Recruiting
Osaka, Japan, 569-1045
Novo Nordisk Investigational Site Recruiting
Osaka, Japan, 574-0074
Novo Nordisk Investigational Site Recruiting
Saga-shi, Saga, Japan, 849-8501
Novo Nordisk Investigational Site Recruiting
Sapporo-shi, Hokkaido, Japan, 062-0003
Novo Nordisk Investigational Site Recruiting
Takamatsu-shi, Kagawa, Japan, 760-8557
Novo Nordisk Investigational Site Recruiting
Tochigi, Japan, 323-0022
Novo Nordisk Investigational Site Recruiting
Tokorozawa-shi, Saitama, Japan, 356-1142
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 103-0027
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 113-8431
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 177-0041
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 192-0918
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 196-0003
Korea, Republic of
Novo Nordisk Investigational Site Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Novo Nordisk Investigational Site Recruiting
Seoul, Korea, Republic of, 02841
Novo Nordisk Investigational Site Recruiting
Seoul, Korea, Republic of, 03722
Novo Nordisk Investigational Site Recruiting
Seoul, Korea, Republic of, 06591
Novo Nordisk Investigational Site Recruiting
Seoul, Korea, Republic of, 138-736
Novo Nordisk Investigational Site Recruiting
Seoul, Korea, Republic of, 139-827
Malaysia
Novo Nordisk Investigational Site Recruiting
Alor Setar, Malaysia, 05460
Novo Nordisk Investigational Site Recruiting
Kota Bharu, Kelantan, Malaysia, 16150
Novo Nordisk Investigational Site Recruiting
Kota Bharu, Malaysia, 15586
Novo Nordisk Investigational Site Recruiting
Kota Samarahan, Malaysia, 94300
Novo Nordisk Investigational Site Recruiting
Kuala Lumpur, Malaysia, 59100
Novo Nordisk Investigational Site Recruiting
Kuching, Malaysia, 93586
Novo Nordisk Investigational Site Recruiting
Putrajaya, Malaysia, 62250
Novo Nordisk Investigational Site Recruiting
Sarawak, Malaysia, 98000
Novo Nordisk Investigational Site Recruiting
Seremban, Malaysia, 70300
Novo Nordisk Investigational Site Recruiting
Sungai Buloh, Malaysia, 47000
Mexico
Novo Nordisk Investigational Site Recruiting
Guadalajara, Jalisco, Mexico, 44600
Novo Nordisk Investigational Site Recruiting
Guadalajara, Jalisco, Mexico, 44650
Novo Nordisk Investigational Site Recruiting
Tlalpan, México, D.F., Mexico, 14080
Novo Nordisk Investigational Site Recruiting
Monterrey, Nuevo León, Mexico, 64020
Novo Nordisk Investigational Site Recruiting
Monterrey, Nuevo León, Mexico, 64060
Novo Nordisk Investigational Site Recruiting
San Nicolas de los Garza, Nuevo León, Mexico, 66465
Novo Nordisk Investigational Site Recruiting
Hermosillo, Sonora, Mexico, 83280
Novo Nordisk Investigational Site Recruiting
Merida, Yucatan, Mexico, 97070
Novo Nordisk Investigational Site Recruiting
Mérida, Yucatan, Mexico, 97070
Novo Nordisk Investigational Site Recruiting
Aguascalientes, Mexico, 20230
Netherlands
Novo Nordisk Investigational Site Recruiting
Amersfoort, Netherlands, 3813 TZ
Novo Nordisk Investigational Site Recruiting
Amsterdam, Netherlands, 1081 HV
Novo Nordisk Investigational Site Recruiting
Apeldoorn, Netherlands, 7334 DZ
Novo Nordisk Investigational Site Recruiting
Delft, Netherlands, 2625 AD
Novo Nordisk Investigational Site Not yet recruiting
Eindhoven, Netherlands, 5631 BM
Novo Nordisk Investigational Site Recruiting
Groningen, Netherlands, 9728 NT
Novo Nordisk Investigational Site Recruiting
Hoogeveen, Netherlands, 7909 AA
Novo Nordisk Investigational Site Recruiting
Maastricht, Netherlands, 6229 HX
Novo Nordisk Investigational Site Recruiting
Nijmegen, Netherlands, 6525 GA
Novo Nordisk Investigational Site Not yet recruiting
Utrecht, Netherlands, 3584 CX
Romania
Novo Nordisk Investigational Site Not yet recruiting
Targoviste, Dambovita, Romania, 130095
Novo Nordisk Investigational Site Not yet recruiting
Targu Mures, Mures, Romania, 540136
Novo Nordisk Investigational Site Not yet recruiting
Tirgu Mures, Mures, Romania, 540142
Novo Nordisk Investigational Site Not yet recruiting
Ploiesti, Prahova, Romania, 100018
Novo Nordisk Investigational Site Not yet recruiting
Ploiesti, Prahova, Romania, 100342
Novo Nordisk Investigational Site Not yet recruiting
Bacau, Romania, 600154
Novo Nordisk Investigational Site Not yet recruiting
Bucharest, Romania, 051811
Russian Federation
Novo Nordisk Investigational Site Recruiting
Barnaul, Russian Federation, 656045
Novo Nordisk Investigational Site Recruiting
Kazan, Russian Federation, 420012
Novo Nordisk Investigational Site Recruiting
Kazan, Russian Federation, 420111
Novo Nordisk Investigational Site Recruiting
Kemerovo, Russian Federation, 650066
Novo Nordisk Investigational Site Not yet recruiting
Moscow, Russian Federation, 119435
Novo Nordisk Investigational Site Recruiting
Novosibirsk, Russian Federation, 630087
Novo Nordisk Investigational Site Recruiting
Novosibirsk, Russian Federation, 630099
Novo Nordisk Investigational Site Recruiting
Penza, Russian Federation, 440026
Novo Nordisk Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 191119
Novo Nordisk Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 194156
Novo Nordisk Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 197110
Novo Nordisk Investigational Site Recruiting
Saratov, Russian Federation, 410039
Novo Nordisk Investigational Site Recruiting
Saratov, Russian Federation, 410053
Novo Nordisk Investigational Site Recruiting
St. Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site Recruiting
Tomsk, Russian Federation, 634050
Novo Nordisk Investigational Site Recruiting
Tumen, Russian Federation, 625023
Novo Nordisk Investigational Site Recruiting
Ulianovsk, Russian Federation, 432063
Novo Nordisk Investigational Site Recruiting
Yaroslavl, Russian Federation, 150062
Novo Nordisk Investigational Site Recruiting
Yoshkar-Ola, Russian Federation, 424004
Serbia
Novo Nordisk Investigational Site Recruiting
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site Not yet recruiting
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site Recruiting
Kragujevac, Serbia, 34000
Novo Nordisk Investigational Site Not yet recruiting
Nis, Serbia, 18000
Novo Nordisk Investigational Site Recruiting
Nis, Serbia, 18000
Novo Nordisk Investigational Site Not yet recruiting
Novi Sad, Serbia, 21000
Slovakia
Novo Nordisk Investigational Site Not yet recruiting
Bratislava, Slovakia, 831 01
Novo Nordisk Investigational Site Not yet recruiting
Bratislava, Slovakia, 833 05
Novo Nordisk Investigational Site Recruiting
Kosice, Slovakia, 040 01
Novo Nordisk Investigational Site Recruiting
Kosice, Slovakia, 04022
Novo Nordisk Investigational Site Not yet recruiting
Krompachy, Slovakia, 05342
Novo Nordisk Investigational Site Recruiting
Nitra, Slovakia, 949 01
Novo Nordisk Investigational Site Recruiting
Poprad, Slovakia, 05845
Novo Nordisk Investigational Site Recruiting
Prievidza, Slovakia, 97101
Novo Nordisk Investigational Site Recruiting
Rimavska Sobota, Slovakia, 97901
Novo Nordisk Investigational Site Recruiting
Roznava, Slovakia, 04801
South Africa
Novo Nordisk Investigational Site Recruiting
Benoni, Gauteng, South Africa, 1501
Novo Nordisk Investigational Site Not yet recruiting
Johannesburg, Gauteng, South Africa, 1619
Novo Nordisk Investigational Site Recruiting
Johannesburg, Gauteng, South Africa, 1818
Novo Nordisk Investigational Site Recruiting
Johannesburg, Gauteng, South Africa, 1827
Novo Nordisk Investigational Site Recruiting
Johannesburg, Gauteng, South Africa, 1829
Novo Nordisk Investigational Site Recruiting
Pretoria, Gauteng, South Africa, 0083
Novo Nordisk Investigational Site Recruiting
Pretoria, Gauteng, South Africa, 0181
Novo Nordisk Investigational Site Recruiting
Berea, KwaZulu-Natal, South Africa, 4091
Novo Nordisk Investigational Site Recruiting
Durban, KwaZulu-Natal, South Africa, 4092
Novo Nordisk Investigational Site Recruiting
Durban, KwaZulu-Natal, South Africa, 4170
Novo Nordisk Investigational Site Recruiting
Durban, KwaZulu-Natal, South Africa, 4450
Novo Nordisk Investigational Site Not yet recruiting
Cape Town, Western Cape, South Africa, 7925
Spain
Novo Nordisk Investigational Site Recruiting
Alcorcón, Spain, 28922
Novo Nordisk Investigational Site Recruiting
Antequera, Spain, 29200
Novo Nordisk Investigational Site Recruiting
Barcelona, Spain, 08003
Novo Nordisk Investigational Site Not yet recruiting
Burela, Spain, 27880
Novo Nordisk Investigational Site Recruiting
Córdoba, Spain, 14004
Novo Nordisk Investigational Site Recruiting
La Coruña, Spain, 15006
Novo Nordisk Investigational Site Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35019
Novo Nordisk Investigational Site Recruiting
Málaga, Spain, 29006
Novo Nordisk Investigational Site Recruiting
Pozuelo de Alarcon, Spain, 28223
Novo Nordisk Investigational Site Recruiting
Sanlúcar De Barrameda - Cádiz-, Spain, 11540
Novo Nordisk Investigational Site Not yet recruiting
Santander, Spain, 39008
Novo Nordisk Investigational Site Recruiting
Santiago de Compostela, Spain, 15706
Novo Nordisk Investigational Site Recruiting
Sevilla, Spain, 41009
Taiwan
Novo Nordisk Investigational Site Recruiting
Changhua City, Taiwan, 500
Novo Nordisk Investigational Site Recruiting
Taichung City, Taiwan, 402
Novo Nordisk Investigational Site Recruiting
Taoyuan, Taiwan, 333
Thailand
Novo Nordisk Investigational Site Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Novo Nordisk Investigational Site Recruiting
Bangkok, Thailand, 10700
Novo Nordisk Investigational Site Recruiting
Chiang Mai, Thailand, 50200
Novo Nordisk Investigational Site Not yet recruiting
Nakhon Ratchasima, Thailand, 30000
Turkey
Novo Nordisk Investigational Site Not yet recruiting
Adana, Turkey
Novo Nordisk Investigational Site Recruiting
Ankara, Turkey, 06010
Novo Nordisk Investigational Site Recruiting
Bursa, Turkey, 16310
Novo Nordisk Investigational Site Recruiting
Erzurum, Turkey, 25240
Novo Nordisk Investigational Site Recruiting
Eskisehir, Turkey, 26040
Novo Nordisk Investigational Site Recruiting
Hatay, Turkey, 31060
Novo Nordisk Investigational Site Recruiting
Istanbul, Turkey, 34096
Novo Nordisk Investigational Site Recruiting
Istanbul, Turkey, 34303
Novo Nordisk Investigational Site Recruiting
Istanbul, Turkey, 34722
Novo Nordisk Investigational Site Recruiting
Izmir, Turkey, 35340
Novo Nordisk Investigational Site Recruiting
Kayseri, Turkey, 38039
Novo Nordisk Investigational Site Recruiting
Sivas, Turkey, 58140
Novo Nordisk Investigational Site Recruiting
Trabzon, Turkey, 61080
Ukraine
Novo Nordisk Investigational Site Recruiting
Cherkasy, Ukraine, 18009
Novo Nordisk Investigational Site Recruiting
Chernivtsi, Ukraine, 58022
Novo Nordisk Investigational Site Recruiting
Kyiv, Ukraine, 04053
Novo Nordisk Investigational Site Recruiting
Lviv, Ukraine, 79010
Novo Nordisk Investigational Site Recruiting
Odesa, Ukraine, 65025
Novo Nordisk Investigational Site Recruiting
Poltava, Ukraine, 36039
Novo Nordisk Investigational Site Recruiting
Uzhhorod, Ukraine, 88000
Novo Nordisk Investigational Site Recruiting
Zhytomyr, Ukraine, 10002
United Kingdom
Novo Nordisk Investigational Site Recruiting
Aberdeen, United Kingdom, AB25 2ZD
Novo Nordisk Investigational Site Recruiting
Addlestone, United Kingdom, KT15 2BH
Novo Nordisk Investigational Site Recruiting
Belfast, United Kingdom, BT12 6BA
Novo Nordisk Investigational Site Recruiting
Bradford-on-Avon, United Kingdom, BA15 1DQ
Novo Nordisk Investigational Site Recruiting
Bristol, United Kingdom, BS10 5NB
Novo Nordisk Investigational Site Recruiting
Cambridge, United Kingdom, CB2 0QQ
Novo Nordisk Investigational Site Recruiting
Chippenham, United Kingdom, SN15 1HP
Novo Nordisk Investigational Site Recruiting
Coventry, United Kingdom, CV2 2DX
Novo Nordisk Investigational Site Recruiting
Edinburgh, United Kingdom, EH4 2XU
Novo Nordisk Investigational Site Recruiting
Glasgow, United Kingdom, G31 2ER
Novo Nordisk Investigational Site Recruiting
Glasgow, United Kingdom, G51 4TF
Novo Nordisk Investigational Site Recruiting
Harrogate, United Kingdom, HG2 7SX
Novo Nordisk Investigational Site Recruiting
Hinckley, United Kingdom, LE10 2SE
Novo Nordisk Investigational Site Recruiting
Hull, United Kingdom, HU3 2RW
Novo Nordisk Investigational Site Recruiting
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site Recruiting
Manchester, United Kingdom, M8 5RB
Novo Nordisk Investigational Site Recruiting
Norfolk, United Kingdom, NR4 7UQ
Novo Nordisk Investigational Site Recruiting
Plymouth, United Kingdom, PL6 8DH
Novo Nordisk Investigational Site Recruiting
Redhill, United Kingdom, RH1 5RH
Novo Nordisk Investigational Site Recruiting
Soham, United Kingdom, CB7 5JD
Novo Nordisk Investigational Site Recruiting
Swansea, United Kingdom, SA2 8PP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03914326    
Other Study ID Numbers: EX9924-4473
2018-003141-42 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1218-5368 ( Other Identifier: World Health Organization (WHO) )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases