A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Last updated: July 11, 2022
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT02692716
NN9924-4221
2015-003563-10
NL56580.091.16
U1111-1173-0750
  • Ages > 50
  • All Genders

Study Summary

This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female diagnosed with type 2 diabetes
  • Age at least 50 years at screening and presence of cardiovascular disease, or age atleast 60 years at screening and presence of at least one cardiovascular risk factor

Exclusion

Exclusion Criteria:

  • Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitoror pramlintide
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullarythyroid carcinoma (MTC)
  • History of pancreatitis (acute or chronic)
  • History of major surgical procedures involving the stomach potentially affectingabsorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,gastric bypass surgery)
  • Subjects presently classified as being in New York Heart Association (NYHA) Class IVheart failure
  • Planned coronary, carotid or peripheral artery revascularisation known on the day ofscreening
  • Any of the following: myocardial infarction, stroke or hospitalisation for unstableangina or transient ischaemic attack within the past 60 days prior to screening
  • Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73m^2)
  • History or presence of malignant neoplasms within the last 5 years (except basal andsquamous cell skin cancer and carcinoma in situ)

Study Design

Total Participants: 3183
Study Start date:
January 17, 2017
Estimated Completion Date:
September 25, 2018

Connect with a study center

  • Novo Nordisk Investigational Site

    Annaba, 23000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Oran, 31000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Setif, 19000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Tizi Ouzou, 16015
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Buenos Aires, B1704ETD
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Caba, C1120AAC
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Cordoba, 5000
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Lanus Este, B1824KAJ
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Curitiba, Parana 80030-110
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Mogi das Cruzes, Sao Paulo 08780-090
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    São José dos Campos, Sao Paulo 12243-280
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    São Paulo, Sao Paulo 01228-200
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Calgary, Alberta T2V 4J2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Edmonton, Alberta T6H 2L4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Brampton, Ontario L6Z 4N5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, Ontario L4K 4M2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Thornhill, Ontario L4J 8L7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Montreal, Quebec H4A 3T2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Westmount, Quebec H3Z 1E5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Aarhus C, 8000
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hellerup, 2900
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Odense, 5000
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Elsterwerda, 04910
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Essen, 45219
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22607
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Münster, 48145
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldenburg, 23758
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldenburg I. Holst, 23758
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderbad, Andhra Pradesh 500 012
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat 380006
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kochi, Kerala 682041
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kozhikode, Kerala 673017
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Thiruvananthapuram, Kerala 695031
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Goa, Maharashtra 403 202
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra 400008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Pune, Maharashtra 411001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi 110029
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Ludhiana, Punjab 141008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu 600086
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal 700054
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Delhi, 110001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Haifa, 35152
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Holon, 58100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Jerusalem, 91120
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Nahariya, 22100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Rishon Le Zion, 75650
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Aviv, 6937947
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Bergamo, 24127
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Catanzaro, 88100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Chieti, 66100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Chieti Scalo, 66100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Milano, 20132
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Palermo, 90127
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Roma, 00161
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Ipoh, Perak, 30990
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kota Bharu, 15586
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kota Bharu, Kelantan, 16150
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kota Samarahan, 94300
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kuala Lumpur, 50400
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kuching, 93586
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Melaka, 75400
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Putrajaya, 62250
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Seremban, 70300
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco 44600
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    San Luis Potosi, 78200
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Almere, 1311RL
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Amsterdam, 1066 EC
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Eindhoven, 5631 BM
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Hoogeveen, 7909 AA
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Krakow, 31-271
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lublin, 20-044
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Poznan, 60-589
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, 01-192
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Oradea, Bihor 410025
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Targu Mures, Mures 540142
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Tirgu Mures, Mures 540142
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Bucharest,
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Galati, 800098
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng 1827
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Lenasia, Gauteng 1827
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4450
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Middleburg, Mpumalanga 1055
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Alcala de Henares, 28805
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Badalona, 08916
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Fuenlabrada - Madrid, 28942
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Madrid, 28046
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Málaga, 29006
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Palma de Mallorca, 07198
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Pontevedra, 36071
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Sevilla, 41003
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Valencia, 46014
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Kaohsiung City, 833
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Taichung City, 407
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tainan city, 710
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangkok, 10700
    Thailand

    Site Not Available

  • Novo Nordisk Investigational Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Novo Nordisk Investigational Site

    Klong Luang, Pathumthani, 12120
    Thailand

    Site Not Available

  • Novo Nordisk Investigational Site

    Nakhon Ratchasima, 30000
    Thailand

    Site Not Available

  • Novo Nordisk Investigational Site

    Ankara, 06100
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Antalya, 07058
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Aydin, 09010
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Denizli, 20070
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Gaziantep, 27070
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Istanbul, 34760
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Izmir, 35100
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Rize, 53020
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Aberdeen, AB25 2ZD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Guildford, GU2 7XX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Norfolk, NR4 7UQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Swansea, SA2 8PP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Watford, WD18 0HB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Searcy, Arkansas 72143
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, California 94520
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    La Jolla, California 92037
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Monterey, California 93940
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Ramon, California 94583
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ventura, California 93003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boca Raton, Florida 33433
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Muncie, Indiana 47304
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa 51501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Slidell, Louisiana 70461-4231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Canton, Michigan 48187
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albany, New York 12206
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Massapequa, New York 11758-1802
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Westfield, New York 14787
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Ohio 43203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Twinsburg, Ohio 44087
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Moncks Corner, South Carolina 29461
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee 37938
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Texas 76012-4637
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hurst, Texas 76054
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Midland, Texas 79707
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78220
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waco, Texas 76710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    South Burlington, Vermont 05403
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norfolk, Virginia 23510-2015
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.