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A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW)

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ClinicalTrials.gov Identifier: NCT03819153
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

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 : 3160 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: Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : August 19, 2024
Estimated Study Completion Date : August 19, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide
Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
Drug: Semaglutide
Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants' dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.

Placebo Comparator: Placebo
Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
Drug: Placebo (semaglutide)
Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject placebo (semaglutide) under their skin. Participants will inject placebo (semaglutide) 1 time a week on the same day of the week. Participants' dose of placebo (semaglutide) will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.




Primary Outcome Measures :
  1. Time to first occurrence of a composite primary outcome event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease [ Time Frame: Week 0 to month 61 ]
    Measured in month(s). End Stage Renal Disease (ESRD) is defined as the following individual components: Persistent estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73m^2 or, Chronic dialysis treatment or receiving a kidney transplantation.


Secondary Outcome Measures :
  1. Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (total eGFR slope) [ Time Frame: Week 0 to month 61 ]
    Measured in (mL/min/1.73 m^2)/year.

  2. Time to first occurrence of a composite cardiovascular major adverse cardiovascular event (MACE) endpoint consisting of: Non-fatal myocardial infarction, non-fatal stroke, and cardiovascular (CV) death [ Time Frame: Week 0 to month 61 ]
    Measured in month(s).

  3. Time to occurrence of all-cause death [ Time Frame: Week 0 to month 61 ]
    Measured in month(s).

  4. Time to occurrence of each of the individual components of the primary composite endpoint and of the confirmatory secondary MACE endpoint [ Time Frame: Week 0 to month 61 ]
    Measured in month(s).

  5. Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: Acute limb ischemia hospitalisation and chronic limb ischemia hospitalisation [ Time Frame: Week 0 to month 61 ]
    Measured in month(s).

  6. Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope) [ Time Frame: Week 12 to month 61 ]
    Measured in (mL/min/1.73 m^2)/year.

  7. Change in eGFR (CKD-EPI) [ Time Frame: Week 0, Week 12 ]
    Measured in mL/min/1.73 m^2.

  8. Change in eGFR (cystatin C CKD-EPI) [ Time Frame: Week 0, Year 3 ]
    Measured in mL/min/1.73 m^2.

  9. Relative change in urinary albumin-to-creatinine ratio (UACR) [ Time Frame: Week 0, Year 3 ]
    Measured in percentage.

  10. Change in body weight [ Time Frame: Week 0, Year 3 ]
    Measured in kilogram.

  11. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, Year 3 ]
    Measured in percentage point.

  12. Change in systolic blood pressure [ Time Frame: Week 0, Year 3 ]
    Measured in mmHg.

  13. Change in diastolic blood pressure [ Time Frame: Week 0, Year 3 ]
    Measured in mmHg.

  14. Number of severe hypoglycaemic episodes [ Time Frame: Week 0 to month 61 ]
    Number of events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
  • Renal impairment defined either by:

    1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
    2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g
  • Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening

Exclusion Criteria:

  • Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
  • Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
  • Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
  • Planned coronary, carotid or peripheral artery revascularisation
  • Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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): NCT03819153


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

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Locations
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United States, Alabama
Novo Nordisk Investigational Site Recruiting
Anniston, Alabama, United States, 36207
Novo Nordisk Investigational Site Recruiting
Tuscumbia, Alabama, United States, 35674
United States, California
Novo Nordisk Investigational Site Recruiting
Chula Vista, California, United States, 91910
Novo Nordisk Investigational Site Recruiting
Concord, California, United States, 94520
Novo Nordisk Investigational Site Recruiting
Fresno, California, United States, 93720
Novo Nordisk Investigational Site Recruiting
La Mesa, California, United States, 91942
Novo Nordisk Investigational Site Not yet recruiting
Lakewood, California, United States, 90805
Novo Nordisk Investigational Site Recruiting
Lancaster, California, United States, 93534
Novo Nordisk Investigational Site Recruiting
Lincoln, California, United States, 95648
Novo Nordisk Investigational Site Recruiting
Loma Linda, California, United States, 92357
Novo Nordisk Investigational Site Recruiting
Long Beach, California, United States, 90807
Novo Nordisk Investigational Site Recruiting
Long Beach, California, United States, 90822
Novo Nordisk Investigational Site Recruiting
Los Angeles, California, United States, 90022
Novo Nordisk Investigational Site Not yet recruiting
Los Angeles, California, United States, 90095
Novo Nordisk Investigational Site Recruiting
Northridge, California, United States, 91324
Novo Nordisk Investigational Site Recruiting
Palm Springs, California, United States, 92262
Novo Nordisk Investigational Site Recruiting
Port Hueneme, California, United States, 93041
Novo Nordisk Investigational Site Recruiting
Rancho Cucamonga, California, United States, 91730-3063
Novo Nordisk Investigational Site Not yet recruiting
Rialto, California, United States, 92377
Novo Nordisk Investigational Site Recruiting
Roseville, California, United States, 95661
Novo Nordisk Investigational Site Recruiting
San Diego, California, United States, 92123
Novo Nordisk Investigational Site Recruiting
San Dimas, California, United States, 91773
Novo Nordisk Investigational Site Recruiting
San Ramon, California, United States, 94583
Novo Nordisk Investigational Site Recruiting
Torrance, California, United States, 90502
Novo Nordisk Investigational Site Recruiting
Van Nuys, California, United States, 91405
United States, Colorado
Novo Nordisk Investigational Site Recruiting
Aurora, Colorado, United States, 80045
Novo Nordisk Investigational Site Recruiting
Denver, Colorado, United States, 80246
United States, Florida
Novo Nordisk Investigational Site Recruiting
Boca Raton, Florida, United States, 33431
Novo Nordisk Investigational Site Recruiting
Clearwater, Florida, United States, 33756
Novo Nordisk Investigational Site Recruiting
Coral Gables, Florida, United States, 33134
Novo Nordisk Investigational Site Recruiting
Fleming Island, Florida, United States, 32003
Novo Nordisk Investigational Site Not yet recruiting
Gainesville, Florida, United States, 32610
Novo Nordisk Investigational Site Recruiting
Hialeah, Florida, United States, 33016
Novo Nordisk Investigational Site Recruiting
Hollywood, Florida, United States, 33021
Novo Nordisk Investigational Site Recruiting
Miami Lakes, Florida, United States, 33014
Novo Nordisk Investigational Site Recruiting
Miami, Florida, United States, 33032
Novo Nordisk Investigational Site Recruiting
Miami, Florida, United States, 33130
Novo Nordisk Investigational Site Not yet recruiting
Miami, Florida, United States, 33144
Novo Nordisk Investigational Site Recruiting
Miami, Florida, United States, 33173
Novo Nordisk Investigational Site Recruiting
New Port Richey, Florida, United States, 34652
Novo Nordisk Investigational Site Not yet recruiting
Orlando, Florida, United States, 32804
Novo Nordisk Investigational Site Recruiting
Pembroke Pines, Florida, United States, 33027
Novo Nordisk Investigational Site Recruiting
Port Charlotte, Florida, United States, 33952
Novo Nordisk Investigational Site Recruiting
Saint Augustine, Florida, United States, 32080
Novo Nordisk Investigational Site Recruiting
Sarasota, Florida, United States, 34239
Novo Nordisk Investigational Site Recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Novo Nordisk Investigational Site Recruiting
Atlanta, Georgia, United States, 30342
Novo Nordisk Investigational Site Suspended
Augusta, Georgia, United States, 30904
Novo Nordisk Investigational Site Recruiting
Lawrenceville, Georgia, United States, 30046
Novo Nordisk Investigational Site Not yet recruiting
Roswell, Georgia, United States, 30075
Novo Nordisk Investigational Site Not yet recruiting
Roswell, Georgia, United States, 30076
United States, Idaho
Novo Nordisk Investigational Site Recruiting
Meridian, Idaho, United States, 83646
Novo Nordisk Investigational Site Recruiting
Nampa, Idaho, United States, 83686-6011
United States, Illinois
Novo Nordisk Investigational Site Recruiting
Chicago, Illinois, United States, 60616
Novo Nordisk Investigational Site Recruiting
Gurnee, Illinois, United States, 60031
Novo Nordisk Investigational Site Not yet recruiting
Gurnee, Illinois, United States, 60031
Novo Nordisk Investigational Site Recruiting
Skokie, Illinois, United States, 60077
United States, Indiana
Novo Nordisk Investigational Site Recruiting
Valparaiso, Indiana, United States, 46383
United States, Iowa
Novo Nordisk Investigational Site Recruiting
Council Bluffs, Iowa, United States, 51501
United States, Kansas
Novo Nordisk Investigational Site Not yet recruiting
Manhattan, Kansas, United States, 66502
United States, Kentucky
Novo Nordisk Investigational Site Recruiting
Paducah, Kentucky, United States, 42003
United States, Louisiana
Novo Nordisk Investigational Site Recruiting
Metairie, Louisiana, United States, 70006
United States, Maryland
Novo Nordisk Investigational Site Not yet recruiting
Annapolis, Maryland, United States, 21401
Novo Nordisk Investigational Site Recruiting
Beltsville, Maryland, United States, 20705
United States, Massachusetts
Novo Nordisk Investigational Site Not yet recruiting
Boston, Massachusetts, United States, 02115-5804
United States, Michigan
Novo Nordisk Investigational Site Recruiting
Buckley, Michigan, United States, 49620
Novo Nordisk Investigational Site Recruiting
Flint, Michigan, United States, 48504
Novo Nordisk Investigational Site Recruiting
Flint, Michigan, United States, 48532
United States, Missouri
Novo Nordisk Investigational Site Recruiting
Kansas City, Missouri, United States, 64111
Novo Nordisk Investigational Site Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Novo Nordisk Investigational Site Not yet recruiting
Omaha, Nebraska, United States, 68198
United States, New Mexico
Novo Nordisk Investigational Site Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Novo Nordisk Investigational Site Recruiting
Albany, New York, United States, 12206
Novo Nordisk Investigational Site Recruiting
Mineola, New York, United States, 11501
Novo Nordisk Investigational Site Not yet recruiting
New York, New York, United States, 10016
Novo Nordisk Investigational Site Recruiting
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27517
Novo Nordisk Investigational Site Recruiting
Morehead City, North Carolina, United States, 28557-4346
Novo Nordisk Investigational Site Recruiting
Morganton, North Carolina, United States, 28655
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
Novo Nordisk Investigational Site Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Investigational Site Not yet recruiting
Cincinnati, Ohio, United States, 45220-2213
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Franklin, Ohio, United States, 45005
Novo Nordisk Investigational Site Recruiting
Maumee, Ohio, United States, 43537
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 Not yet recruiting
Bethlehem, Pennsylvania, United States, 18017
Novo Nordisk Investigational Site Recruiting
Jersey Shore, Pennsylvania, United States, 17740
Novo Nordisk Investigational Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19114
Novo Nordisk Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224-2215
United States, South Carolina
Novo Nordisk Investigational Site Recruiting
Little River, South Carolina, United States, 29566
Novo Nordisk Investigational Site Recruiting
Murrells Inlet, South Carolina, United States, 29576
Novo Nordisk Investigational Site Recruiting
Myrtle Beach, South Carolina, United States, 29588
Novo Nordisk Investigational Site Not yet recruiting
Orangeburg, South Carolina, United States, 39118
United States, Tennessee
Novo Nordisk Investigational Site Recruiting
Bartlett, Tennessee, United States, 38133
Novo Nordisk Investigational Site Recruiting
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Novo Nordisk Investigational Site Not yet recruiting
Austin, Texas, United States, 78705
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, 78751
Novo Nordisk Investigational Site Recruiting
Corpus Christi, Texas, United States, 78414
Novo Nordisk Investigational Site Not yet recruiting
Dallas, Texas, United States, 75226
Novo Nordisk Investigational Site Recruiting
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site Recruiting
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site Recruiting
El Paso, Texas, United States, 79935
Novo Nordisk Investigational Site Not yet recruiting
Houston, Texas, United States, 77004-7642
Novo Nordisk Investigational Site Recruiting
Houston, Texas, United States, 77040
Novo Nordisk Investigational Site Recruiting
Houston, Texas, United States, 77081
Novo Nordisk Investigational Site Not yet recruiting
Houston, Texas, United States, 77099
Novo Nordisk Investigational Site Recruiting
Rockwall, Texas, United States, 75032
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78215
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78224
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78230
Novo Nordisk Investigational Site Recruiting
Schertz, Texas, United States, 78154
Novo Nordisk Investigational Site Recruiting
Sugar Land, Texas, United States, 77478
United States, Utah
Novo Nordisk Investigational Site Recruiting
Ogden, Utah, United States, 84405
United States, Vermont
Novo Nordisk Investigational Site Not yet recruiting
South Burlington, Vermont, United States, 05403
United States, Virginia
Novo Nordisk Investigational Site Recruiting
Norfolk, Virginia, United States, 23510-2015
Novo Nordisk Investigational Site Recruiting
Salem, Virginia, United States, 24153-6404
Novo Nordisk Investigational Site Recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Novo Nordisk Investigational Site Recruiting
Olympia, Washington, United States, 98502
Novo Nordisk Investigational Site Recruiting
Spokane, Washington, United States, 99202
Novo Nordisk Investigational Site Not yet recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Novo Nordisk Investigational Site Not yet recruiting
Wauwatosa, Wisconsin, United States, 53226
Argentina
Novo Nordisk Investigational Site Recruiting
Buenos Aires, Argentina, C1250AAN
Novo Nordisk Investigational Site Recruiting
Buenos Aires, Argentina, C1425AGC
Novo Nordisk Investigational Site Recruiting
Caba, Argentina, 1425
Novo Nordisk Investigational Site Recruiting
Caba, Argentina, 1429
Novo Nordisk Investigational Site Recruiting
Caba, Argentina, C1430CKE
Novo Nordisk Investigational Site Recruiting
Caba, Argentina, C1440AAD
Novo Nordisk Investigational Site Recruiting
Villa Dominico, Argentina, B1872EEA
Australia, New South Wales
Novo Nordisk Investigational Site Recruiting
Gosford, New South Wales, Australia, 2250
Novo Nordisk Investigational Site Not yet recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Novo Nordisk Investigational Site Not yet recruiting
Milton, Queensland, Australia, 4064
Australia, Victoria
Novo Nordisk Investigational Site Recruiting
Caulfield, Victoria, Australia, 3162
Novo Nordisk Investigational Site Not yet recruiting
Clayton, Victoria, Australia, 3168
Novo Nordisk Investigational Site Recruiting
Fitzroy, Victoria, Australia, 3065
Novo Nordisk Investigational Site Recruiting
Parkville, Victoria, Australia, 3050
Belgium
Novo Nordisk Investigational Site Recruiting
Bonheiden, Belgium, 2820
Novo Nordisk Investigational Site Recruiting
Bruxelles, Belgium, 1200
Novo Nordisk Investigational Site Recruiting
Edegem, Belgium, 2650
Novo Nordisk Investigational Site Not yet recruiting
Gent, Belgium, 9000
Novo Nordisk Investigational Site Recruiting
Jette, Belgium, 1090
Novo Nordisk Investigational Site Recruiting
Leuven, Belgium, 3000
Novo Nordisk Investigational Site Recruiting
Liège, Belgium, 4000
Novo Nordisk Investigational Site Recruiting
Roeselare, Belgium, 8800
Brazil
Novo Nordisk Investigational Site Recruiting
Fortaleza, Ceara, Brazil, 60170-195
Novo Nordisk Investigational Site Recruiting
Curitiba, Parana, Brazil, 80440-020
Novo Nordisk Investigational Site Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
Novo Nordisk Investigational Site Not yet recruiting
Santo André, Sao Paulo, Brazil, 09030-340
Novo Nordisk Investigational Site Not yet recruiting
São Paulo, Sao Paulo, Brazil, 01223-001
Novo Nordisk Investigational Site Recruiting
São Paulo, Sao Paulo, Brazil, 01228-000
Novo Nordisk Investigational Site Recruiting
São Paulo, Sao Paulo, Brazil, 01228-200
Bulgaria
Novo Nordisk Investigational Site Recruiting
Plovdiv, Bulgaria, 4001
Novo Nordisk Investigational Site Recruiting
Sliven, Bulgaria, 8800
Novo Nordisk Investigational Site Recruiting
Smolyan, Bulgaria, 4700
Novo Nordisk Investigational Site Recruiting
Sofia, Bulgaria, 1431
Novo Nordisk Investigational Site Recruiting
Sofia, Bulgaria, 1784
Canada, Alberta
Novo Nordisk Investigational Site Recruiting
Calgary, Alberta, Canada, T2H 2G4
Novo Nordisk Investigational Site Recruiting
Calgary, Alberta, Canada, T2T 5C7
Novo Nordisk Investigational Site Not yet recruiting
Edmonton, Alberta, Canada, T6G 2E1
Novo Nordisk Investigational Site Recruiting
Red Deer, Alberta, Canada, T4N 6V7
Canada, British Columbia
Novo Nordisk Investigational Site Recruiting
Vancouver, British Columbia, Canada, V5Z 3W2
Canada, Newfoundland and Labrador
Novo Nordisk Investigational Site Not yet recruiting
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
Canada, Nova Scotia
Novo Nordisk Investigational Site Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
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
Burlington, Ontario, Canada, L7M 4Y1
Novo Nordisk Investigational Site Recruiting
Concord, Ontario, Canada, L4K 4M2
Novo Nordisk Investigational Site Recruiting
Etobicoke, Ontario, Canada, M9R 4E1
Novo Nordisk Investigational Site Suspended
Hamilton, Ontario, Canada, L8J 0B6
Novo Nordisk Investigational Site Recruiting
Hamilton, Ontario, Canada, L8M 1K7
Novo Nordisk Investigational Site Recruiting
London, Ontario, Canada, N5W 6A2
Novo Nordisk Investigational Site Recruiting
Nepean, Ontario, Canada, K2J 0V2
Novo Nordisk Investigational Site Not yet recruiting
Oshawa, Ontario, Canada, L1G 2B9
Novo Nordisk Investigational Site Recruiting
Oshawa, Ontario, Canada, L1J 2K1
Novo Nordisk Investigational Site Recruiting
Sarnia, Ontario, Canada, N7T 4X3
Novo Nordisk Investigational Site Not yet recruiting
Scarborough, Ontario, Canada, M1H 3G4
Novo Nordisk Investigational Site Recruiting
Toronto, Ontario, Canada, M4G 3E8
Novo Nordisk Investigational Site Not yet recruiting
Toronto, Ontario, Canada, M5G 2N2
Novo Nordisk Investigational Site Not yet recruiting
Toronto, Ontario, Canada, M5T 3L9
Novo Nordisk Investigational Site Recruiting
Toronto, Ontario, Canada, M9V 4B4
Canada, Quebec
Novo Nordisk Investigational Site Recruiting
Laval, Quebec, Canada, H7T 2P5
Novo Nordisk Investigational Site Recruiting
Montreal, Quebec, Canada, H2K 1H2
Novo Nordisk Investigational Site Not yet recruiting
Montreal, Quebec, Canada, H2W 1R7
Novo Nordisk Investigational Site Recruiting
Montreal, Quebec, Canada, H4A 3T2
Novo Nordisk Investigational Site Recruiting
Montreal, Quebec, Canada, H4N 2W2
Canada
Novo Nordisk Investigational Site Recruiting
Quebec, Canada, G1W 4R4
Novo Nordisk Investigational Site Recruiting
St John's, Canada, A1B 3V6
China, Beijing
Novo Nordisk Investigational Site Not yet recruiting
Beijing, Beijing, China, 100044
China, Jiangsu
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
Novo Nordisk Investigational Site Not yet recruiting
Beijing, China, 101200
France
Novo Nordisk Investigational Site Recruiting
Annonay, France, 07100
Novo Nordisk Investigational Site Recruiting
BRON cedex, France, 69677
Novo Nordisk Investigational Site Recruiting
Caen, France, 14033
Novo Nordisk Investigational Site Recruiting
Grenoble - Cédex 09, France, 38043
Novo Nordisk Investigational Site Recruiting
La Roche-sur-yon, France, 85925
Novo Nordisk Investigational Site Not yet recruiting
Le Creusot, France, 71200
Novo Nordisk Investigational Site Suspended
Paris, France, 75019
Novo Nordisk Investigational Site Recruiting
Saint Herblain, France, 44800
Novo Nordisk Investigational Site Recruiting
TOULOUSE cedex, France, 31054
Novo Nordisk Investigational Site Recruiting
Venissieux, France, 69200
Germany
Novo Nordisk Investigational Site Not yet recruiting
Bad Mergentheim, Germany, 97980
Novo Nordisk Investigational Site Recruiting
Bad Oeynhausen, Germany, 32545
Novo Nordisk Investigational Site Recruiting
Düsseldorf, Germany, 40210
Novo Nordisk Investigational Site Not yet recruiting
Erlangen, Germany, 91054
Novo Nordisk Investigational Site Recruiting
Essen, Germany, 45136
Novo Nordisk Investigational Site Recruiting
Essen, Germany, 45219
Novo Nordisk Investigational Site Recruiting
Hamburg, Germany, 22607
Novo Nordisk Investigational Site Not yet recruiting
Münster, Germany, 48145
Novo Nordisk Investigational Site Recruiting
Saint Ingbert-Oberwürzbach, Germany, 66386
Greece
Novo Nordisk Investigational Site Recruiting
Athens, Greece, GR-11527
Novo Nordisk Investigational Site Recruiting
Athens, Greece, GR-17562
Novo Nordisk Investigational Site Not yet recruiting
Haidari-Athens, Greece, GR-12462
Novo Nordisk Investigational Site Recruiting
Lamia, Greece, GR35100
Novo Nordisk Investigational Site Not yet recruiting
Thessaloniki, Greece, GR-57001
Hungary
Novo Nordisk Investigational Site Not yet recruiting
Budapest, Hungary, 1076
Novo Nordisk Investigational Site Recruiting
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site Recruiting
Debrecen, Hungary, H-4032
Novo Nordisk Investigational Site Recruiting
Gyula, Hungary, H-5700
Novo Nordisk Investigational Site Not yet recruiting
Nagykanizsa, Hungary, 8800
Novo Nordisk Investigational Site Recruiting
Pécs, Hungary, 7623
Novo Nordisk Investigational Site Recruiting
Siófok, Hungary, 8600
Novo Nordisk Investigational Site Recruiting
Szombathely, Hungary, H-9700
India
Novo Nordisk Investigational Site Recruiting
Hyderbad, Andhra Pradesh, India, 500 012
Novo Nordisk Investigational Site Not yet recruiting
Bangalore, Karnataka, India, 560054
Novo Nordisk Investigational Site Not yet recruiting
Chennai, Tamil Nadu, India, 600037
Novo Nordisk Investigational Site Recruiting
Lucknow, Uttar Pradesh, India, 226005
Novo Nordisk Investigational Site Not yet recruiting
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site Not yet recruiting
New Delhi, India, 110017
Israel
Novo Nordisk Investigational Site Recruiting
Holon, Israel, 58100
Novo Nordisk Investigational Site Recruiting
Jerusalem, Israel, 91120
Novo Nordisk Investigational Site Recruiting
Kfar Saba, Israel, 4428164
Novo Nordisk Investigational Site Recruiting
Rehovot, Israel, 7661041
Italy
Novo Nordisk Investigational Site Recruiting
Bergamo, Italy, 24127
Novo Nordisk Investigational Site Not yet recruiting
Milano, Italy, 20122
Novo Nordisk Investigational Site Recruiting
Milano, Italy, 20132
Novo Nordisk Investigational Site Not yet recruiting
Milano, Italy, 20157
Novo Nordisk Investigational Site Not yet recruiting
Palermo, Italy, 90127
Novo Nordisk Investigational Site Not yet recruiting
Pisa, Italy, 56124
Novo Nordisk Investigational Site Not yet recruiting
Roma, Italy, 00161
Novo Nordisk Investigational Site Recruiting
Roma, Italy, 00189
Japan
Novo Nordisk Investigational Site Recruiting
Chiba, Japan, 271-0077
Novo Nordisk Investigational Site Recruiting
Fukui, Japan, 910-8526
Novo Nordisk Investigational Site Recruiting
Fukuoka, Japan, 816-0864
Novo Nordisk Investigational Site Recruiting
Fukushima, Japan, 963-8851
Novo Nordisk Investigational Site Recruiting
Gunma, Japan, 373-0036
Novo Nordisk Investigational Site Recruiting
Hokkaido, Japan, 060-0062
Novo Nordisk Investigational Site Recruiting
Hokkaido, Japan, 062-0007
Novo Nordisk Investigational Site Recruiting
Ibaraki, Japan, 311-0113
Novo Nordisk Investigational Site Recruiting
Ishikawa, Japan, 920-0293
Novo Nordisk Investigational Site Recruiting
Kanagawa, Japan, 232-0064
Novo Nordisk Investigational Site Recruiting
Kanagawa, Japan, 235-0045
Novo Nordisk Investigational Site Recruiting
Kanagawa, Japan, 247-0055
Novo Nordisk Investigational Site Recruiting
Kumamoto, Japan, 862-0976
Novo Nordisk Investigational Site Recruiting
Kyoto, Japan, 611-0041
Novo Nordisk Investigational Site Recruiting
Miyazaki, Japan, 880-0034
Novo Nordisk Investigational Site Recruiting
Okayama, Japan, 701-0192
Novo Nordisk Investigational Site Recruiting
Osaka, Japan, 569-1045
Novo Nordisk Investigational Site Recruiting
Saitama, Japan, 336-0967
Novo Nordisk Investigational Site Recruiting
Tochigi, Japan, 323-0022
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 103-0027
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 103-0028
Novo Nordisk Investigational Site Not yet recruiting
Tokyo, Japan, 113-8431
Novo Nordisk Investigational Site Not yet recruiting
Tokyo, Japan, 113-8655
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 125-0054
Novo Nordisk Investigational Site Recruiting
Tokyo, Japan, 177-0041
Malaysia
Novo Nordisk Investigational Site Recruiting
Alor Setar, Malaysia, 05460
Novo Nordisk Investigational Site Recruiting
Ipoh, Perak, Malaysia, 30990
Novo Nordisk Investigational Site Recruiting
Kuala Lumpur, Malaysia, 59100
Novo Nordisk Investigational Site Recruiting
Kuching, Malaysia, 93586
Novo Nordisk Investigational Site Recruiting
Pulau Pinang, Malaysia, 10990
Novo Nordisk Investigational Site Recruiting
Serdang, Malaysia, 43000
Mexico
Novo Nordisk Investigational Site Recruiting
Actopan, Hidalgo, Mexico, 42500
Novo Nordisk Investigational Site Recruiting
Guadalajara, Jalisco, Mexico, 44600
Novo Nordisk Investigational Site Recruiting
Distrito Federal, México, D.F., Mexico, 14080
Novo Nordisk Investigational Site Recruiting
Mexico City, México, D.F., Mexico, 14080
Novo Nordisk Investigational Site Recruiting
Culiacán, Sinaloa, Mexico, 80230
Novo Nordisk Investigational Site Recruiting
Ciudad Madero, Tamaulipas, Mexico, 89440
Netherlands
Novo Nordisk Investigational Site Not yet recruiting
Alkmaar, Netherlands, 1815 JD
Novo Nordisk Investigational Site Not yet recruiting
Almelo, Netherlands, 7609 PP
Novo Nordisk Investigational Site Recruiting
Almere, Netherlands, 1311RL
Novo Nordisk Investigational Site Recruiting
Amersfoort, Netherlands, 3813 TZ
Novo Nordisk Investigational Site Not yet recruiting
Amsterdam, Netherlands, 1061 AE
Novo Nordisk Investigational Site Recruiting
Amsterdam, Netherlands, 1081 HV
Novo Nordisk Investigational Site Not yet recruiting
Arnhem, Netherlands, 6815 AD
Novo Nordisk Investigational Site Not yet recruiting
Hilversum, Netherlands, 1213 XZ
Novo Nordisk Investigational Site Not yet recruiting
Utrecht, Netherlands, 3584 CX
Poland
Novo Nordisk Investigational Site Recruiting
Kielce, Poland, 25-035
Novo Nordisk Investigational Site Recruiting
Olsztyn, Poland, 10-561
Novo Nordisk Investigational Site Recruiting
Poznan, Poland, 60-589
Novo Nordisk Investigational Site Recruiting
Radom, Poland, 26-600
Novo Nordisk Investigational Site Recruiting
Szczecin, Poland, 70-111
Novo Nordisk Investigational Site Suspended
Warszawa, Poland, 01-192
Novo Nordisk Investigational Site Not yet recruiting
Warszawa, Poland, 04-749
Novo Nordisk Investigational Site Recruiting
Zabrze, Poland, 41-800
Russian Federation
Novo Nordisk Investigational Site Recruiting
Barnaul, Russian Federation, 656045
Novo Nordisk Investigational Site Recruiting
Kazan, Russian Federation, 420061
Novo Nordisk Investigational Site Recruiting
Kemerovo, Russian Federation, 650066
Novo Nordisk Investigational Site Recruiting
Moscow, Russian Federation, 117036
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, 190013
Novo Nordisk Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 194156
Novo Nordisk Investigational Site Recruiting
Saratov, Russian Federation, 410039
Novo Nordisk Investigational Site Recruiting
Ulianovsk, Russian Federation, 432063
Novo Nordisk Investigational Site Recruiting
Voronezh, Russian Federation, 394018
Novo Nordisk Investigational Site Recruiting
Yoshkar-Ola, Russian Federation, 424004
Slovakia
Novo Nordisk Investigational Site Recruiting
Bratislava, Slovakia, 851 01
Novo Nordisk Investigational Site Recruiting
Kosice, Slovakia, 04011
Novo Nordisk Investigational Site Not yet recruiting
Lubochna, Slovakia, 03491
Novo Nordisk Investigational Site Recruiting
Lucenec, Slovakia, 984 01
Novo Nordisk Investigational Site Recruiting
Nitra, Slovakia, 94901
Novo Nordisk Investigational Site Recruiting
Trebisov, Slovakia, 07501
Novo Nordisk Investigational Site Not yet recruiting
Trstena, Slovakia, 02801
Novo Nordisk Investigational Site Not yet recruiting
Zilina, Slovakia, 010 01
Novo Nordisk Investigational Site Not yet recruiting
Zilina, Slovakia, 010 08
Novo Nordisk Investigational Site Recruiting
Zilina, Slovakia, 01001
South Africa
Novo Nordisk Investigational Site Not yet recruiting
Bloemfontein, Free State, South Africa, 9300
Novo Nordisk Investigational Site Recruiting
Benoni, Gauteng, South Africa, 1501
Novo Nordisk Investigational Site Not yet recruiting
Cosmo City, Gauteng, South Africa, 2188
Novo Nordisk Investigational Site Not yet 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, 2013
Novo Nordisk Investigational Site Recruiting
Durban, KwaZulu-Natal, South Africa, 4092
Novo Nordisk Investigational Site Recruiting
Cape Town, Western Cape, South Africa, 7925
Novo Nordisk Investigational Site Recruiting
Cape Town, South Africa, 7530
Spain
Novo Nordisk Investigational Site Recruiting
Barcelona, Spain, 08003
Novo Nordisk Investigational Site Recruiting
Barcelona, Spain, 08035
Novo Nordisk Investigational Site Recruiting
Burela, Spain, 27880
Novo Nordisk Investigational Site Not yet recruiting
Getafe, Spain
Novo Nordisk Investigational Site Recruiting
Valencia, Spain, 46010
Novo Nordisk Investigational Site Recruiting
Valencia, Spain, 46017
Thailand
Novo Nordisk Investigational Site Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Novo Nordisk Investigational Site Not yet recruiting
Bangkok, Thailand, 10700
Novo Nordisk Investigational Site Recruiting
Chiang Mai, Thailand, 50200
Turkey
Novo Nordisk Investigational Site Not yet recruiting
Adana, Turkey, 01330
Novo Nordisk Investigational Site Not yet recruiting
Ankara, Turkey, 06100
Novo Nordisk Investigational Site Recruiting
Ankara, Turkey, 06230
Novo Nordisk Investigational Site Recruiting
Ankara, Turkey, 06500
Novo Nordisk Investigational Site Not yet recruiting
Antalya, Turkey, 07058
Novo Nordisk Investigational Site Recruiting
Istanbul, Turkey, 34098
Novo Nordisk Investigational Site Not yet recruiting
Istanbul, Turkey, 34390
Novo Nordisk Investigational Site Recruiting
Istanbul, Turkey, 34722
Novo Nordisk Investigational Site Recruiting
Istanbul, Turkey, 34899
Novo Nordisk Investigational Site Not yet recruiting
Izmir, Turkey, 35100
Novo Nordisk Investigational Site Recruiting
Kahramanmaras, Turkey, 46040
Ukraine
Novo Nordisk Investigational Site Recruiting
Dnipro, Ukraine, 49000
Novo Nordisk Investigational Site Recruiting
Ivano-Frankivsk, Ukraine, 76008
Novo Nordisk Investigational Site Recruiting
Kharkiv, Ukraine, 61039
Novo Nordisk Investigational Site Recruiting
Kyiv, Ukraine, 04114
Novo Nordisk Investigational Site Recruiting
Zaporizhia, Ukraine, 69001
United Kingdom
Novo Nordisk Investigational Site Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Novo Nordisk Investigational Site Recruiting
Birmingham, United Kingdom, B9 5SS
Novo Nordisk Investigational Site Recruiting
Cardiff, United Kingdom, CF5 4AD
Novo Nordisk Investigational Site Recruiting
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site Recruiting
Edinburgh, United Kingdom, EH4 2XU
Novo Nordisk Investigational Site Not yet recruiting
Glasgow, United Kingdom, G31 2ER
Novo Nordisk Investigational Site Recruiting
Ipswich, United Kingdom, IP4 5PD
Novo Nordisk Investigational Site Recruiting
London, United Kingdom, N18 1QX
Novo Nordisk Investigational Site Recruiting
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site Recruiting
Stevenage, United Kingdom, SG1 4AB
Novo Nordisk Investigational Site Recruiting
Tooting, United Kingdom, SW17 0RE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
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: NCT03819153     History of Changes
Other Study ID Numbers: NN9535-4321
U1111-1217-6259 ( Other Identifier: World Health Organization (WHO) )
2018-002878-50 ( Registry Identifier: European Medicines Agency (EudraCT) )
JapicCTI-194843 ( Registry Identifier: JAPIC (Japan) )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
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: https://www.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:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency