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A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6)

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ClinicalTrials.gov Identifier: NCT02692716
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
Actual Study Start Date : January 17, 2017
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : September 25, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Oral semaglutide Drug: semaglutide
For oral use once daily.

Placebo Comparator: Placebo Drug: placebo
For oral use once daily.




Primary Outcome Measures :
  1. Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE) composite endpoint consisting of: cardiovascular death, non-fatal myocardial infarction or non-fatal stroke [ Time Frame: From randomisation up to 19 months ]

Secondary Outcome Measures :
  1. From randomisation to first occurrence of an expanded composite cardiovascular endpoint consisting of: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or hospitalisation for heart failure [ Time Frame: From randomisation up to 19 months ]
  2. Time from randomisation to first occurrence of each of the individual components in the expanded composite cardiovascular endpoint [ Time Frame: From randomisation up to 19 months ]
  3. Time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction or non-fatal stroke [ Time Frame: From randomisation up to 19 months ]


Information from the National Library of Medicine

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

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) inhibitor or pramlintide
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
  • History of pancreatitis (acute or chronic)
  • History of major surgical procedures involving the stomach potentially affecting absorption 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 IV heart failure
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina 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/1.73 m^2)
  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

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): NCT02692716


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Locations
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United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72211
Novo Nordisk Investigational Site
Searcy, Arkansas, United States, 72143
United States, California
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92648
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
La Mesa, California, United States, 91942
Novo Nordisk Investigational Site
Lancaster, California, United States, 93534
Novo Nordisk Investigational Site
Monterey, California, United States, 93940
Novo Nordisk Investigational Site
San Diego, California, United States, 92111
Novo Nordisk Investigational Site
San Ramon, California, United States, 94583
Novo Nordisk Investigational Site
Ventura, California, United States, 93003
United States, Florida
Novo Nordisk Investigational Site
Boca Raton, Florida, United States, 33433
Novo Nordisk Investigational Site
New Port Richey, Florida, United States, 34652
United States, Georgia
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
Novo Nordisk Investigational Site
Savannah, Georgia, United States, 31406
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62702
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
Novo Nordisk Investigational Site
Michigan City, Indiana, United States, 46360
Novo Nordisk Investigational Site
Muncie, Indiana, United States, 47304
United States, Iowa
Novo Nordisk Investigational Site
Council Bluffs, Iowa, United States, 51501
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40502
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40213
United States, Louisiana
Novo Nordisk Investigational Site
Monroe, Louisiana, United States, 71203
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Michigan
Novo Nordisk Investigational Site
Canton, Michigan, United States, 48187
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48098
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
Novo Nordisk Investigational Site
North Massapequa, New York, United States, 11758-1802
Novo Nordisk Investigational Site
Westfield, New York, United States, 14787
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Novo Nordisk Investigational Site
Fargo, North Dakota, United States, 58104
United States, Ohio
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44195
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43203
Novo Nordisk Investigational Site
Maumee, Ohio, United States, 43537
United States, Pennsylvania
Novo Nordisk Investigational Site
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Novo Nordisk Investigational Site
Anderson, South Carolina, United States, 29621
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, United States, 29461
Novo Nordisk Investigational Site
Myrtle Beach, South Carolina, United States, 29572
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
Novo Nordisk Investigational Site
Knoxville, Tennessee, United States, 37938
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37203
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76012-4637
Novo Nordisk Investigational Site
Austin, Texas, United States, 78705
Novo Nordisk Investigational Site
Austin, Texas, United States, 78731
Novo Nordisk Investigational Site
Austin, Texas, United States, 78749
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
Hurst, Texas, United States, 76054
Novo Nordisk Investigational Site
Midland, Texas, United States, 79707
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78220
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78228-6205
Novo Nordisk Investigational Site
Waco, Texas, United States, 76710
United States, Vermont
Novo Nordisk Investigational Site
South Burlington, Vermont, United States, 05403
United States, Virginia
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23510-2015
Novo Nordisk Investigational Site
Winchester, Virginia, United States, 22601-3834
Algeria
Novo Nordisk Investigational Site
Annaba, Algeria, 23000
Novo Nordisk Investigational Site
Oran, Algeria, 31000
Novo Nordisk Investigational Site
Setif, Algeria, 19000
Novo Nordisk Investigational Site
Tizi Ouzou, Algeria, 16015
Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1704ETD
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1428ART
Novo Nordisk Investigational Site
Caba, Argentina, C1120AAC
Novo Nordisk Investigational Site
Caba, Argentina, C1440AAD
Novo Nordisk Investigational Site
Cordoba, Argentina, 5000
Novo Nordisk Investigational Site
Lanus Este, Argentina, B1824KAJ
Brazil
Novo Nordisk Investigational Site
Curitiba, Parana, Brazil, 80030-110
Novo Nordisk Investigational Site
Mogi das Cruzes, Sao Paulo, Brazil, 08780-090
Novo Nordisk Investigational Site
São José dos Campos, Sao Paulo, Brazil, 12243-280
Novo Nordisk Investigational Site
São Paulo, Sao Paulo, Brazil, 01228-200
Canada, Alberta
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T2V 4J2
Novo Nordisk Investigational Site
Edmonton, Alberta, Canada, T6H 2L4
Canada, Ontario
Novo Nordisk Investigational Site
Brampton, Ontario, Canada, L6T 0G1
Novo Nordisk Investigational Site
Brampton, Ontario, Canada, L6Z 4N5
Novo Nordisk Investigational Site
Concord, Ontario, Canada, L4K 4M2
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H4A 3T2
Denmark
Novo Nordisk Investigational Site
Aarhus N, Denmark, 8200
Novo Nordisk Investigational Site
Esbjerg, Denmark, 6700
Novo Nordisk Investigational Site
Hellerup, Denmark, 2900
Novo Nordisk Investigational Site
Hvidovre, Denmark, 2650
Novo Nordisk Investigational Site
Odense, Denmark, 5000
Germany
Novo Nordisk Investigational Site
Bochum, Germany, 44791
Novo Nordisk Investigational Site
Dresden, Germany, 01307
Novo Nordisk Investigational Site
Elsterwerda, Germany, 04910
Novo Nordisk Investigational Site
Essen, Germany, 45219
Novo Nordisk Investigational Site
Falkensee, Germany, 14612
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Ludwigshafen, Germany, 67059
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Oldenburg, Germany, 23758
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, Germany, 66386
India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500034
Novo Nordisk Investigational Site
Hyderbad, Andhra Pradesh, India, 500 012
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380006
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380052
Novo Nordisk Investigational Site
Kochi, Kerala, India, 682041
Novo Nordisk Investigational Site
Kozhikode, Kerala, India, 673017
Novo Nordisk Investigational Site
Thiruvananthapuram, Kerala, India, 695031
Novo Nordisk Investigational Site
Goa, Maharashtra, India, 403 202
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400012
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411001
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411004
Novo Nordisk Investigational Site
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site
Ludhiana, Punjab, India, 141008
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site
New Delhi, India, 110001
Novo Nordisk Investigational Site
New Delhi, India, 110017
Novo Nordisk Investigational Site
Pune, India, 411011
Israel
Novo Nordisk Investigational Site
Haifa, Israel, 35152
Novo Nordisk Investigational Site
Holon, Israel, 58100
Novo Nordisk Investigational Site
Jerusalem, Israel, 91120
Novo Nordisk Investigational Site
Nahariya, Israel, 22100
Novo Nordisk Investigational Site
Petah-Tikva, Israel, 49100
Novo Nordisk Investigational Site
Rishon Le Zion, Israel, 75650
Novo Nordisk Investigational Site
Tel Aviv, Israel, 6937947
Novo Nordisk Investigational Site
Tel-Aviv, Israel, 64239
Italy
Novo Nordisk Investigational Site
Bergamo, Italy, 24127
Novo Nordisk Investigational Site
Catanzaro, Italy, 88100
Novo Nordisk Investigational Site
Chieti, Italy, 66100
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
Palermo, Italy, 90127
Novo Nordisk Investigational Site
Roma, Italy, 00133
Novo Nordisk Investigational Site
Roma, Italy, 00161
Malaysia
Novo Nordisk Investigational Site
Ipoh, Perak, Malaysia, 30990
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Novo Nordisk Investigational Site
Kota Bharu, Malaysia, 15586
Novo Nordisk Investigational Site
Kota Samarahan, Malaysia, 94300
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 50400
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 59100
Novo Nordisk Investigational Site
Kuching, Malaysia, 93586
Novo Nordisk Investigational Site
Melaka, Malaysia, 75400
Novo Nordisk Investigational Site
Putrajaya, Malaysia, 62250
Novo Nordisk Investigational Site
Seremban, Malaysia, 70300
Mexico
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44600
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44670
Novo Nordisk Investigational Site
Monterrey, Nuevo León, Mexico, 64460
Novo Nordisk Investigational Site
Merida, Yucatan, Mexico, 97070
Novo Nordisk Investigational Site
San Luis Potosi, Mexico, 78200
Netherlands
Novo Nordisk Investigational Site
Almere, Netherlands, 1311RL
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1066 EC
Novo Nordisk Investigational Site
Eindhoven, Netherlands, 5631 BM
Novo Nordisk Investigational Site
Hoogeveen, Netherlands, 7909 AA
Novo Nordisk Investigational Site
Nijmegen, Netherlands, 6525 GA
Poland
Novo Nordisk Investigational Site
Krakow, Poland, 31-261
Novo Nordisk Investigational Site
Krakow, Poland, 31-271
Novo Nordisk Investigational Site
Lublin, Poland, 20-044
Novo Nordisk Investigational Site
Poznan, Poland, 60-589
Novo Nordisk Investigational Site
Warszawa, Poland, 01-192
Romania
Novo Nordisk Investigational Site
Oradea, Bihor, Romania, 410025
Novo Nordisk Investigational Site
Targu Mures, Mures, Romania, 540142
Novo Nordisk Investigational Site
Bucharest, Romania, 010507
Novo Nordisk Investigational Site
Bucharest, Romania, 020359
Novo Nordisk Investigational Site
Bucharest, Romania, 020475
Novo Nordisk Investigational Site
Bucharest, Romania
Novo Nordisk Investigational Site
Galati, Romania, 800098
South Africa
Novo Nordisk Investigational Site
Bloemfontein, Free State, South Africa, 9301
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1827
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2013
Novo Nordisk Investigational Site
Lenasia, Gauteng, South Africa, 1827
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0181
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4450
Novo Nordisk Investigational Site
Middleburg, Mpumalanga, South Africa, 1055
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7925
Spain
Novo Nordisk Investigational Site
Alcala de Henares, Spain, 28805
Novo Nordisk Investigational Site
Badalona, Spain, 08916
Novo Nordisk Investigational Site
Fuenlabrada - Madrid, Spain, 28942
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Málaga, Spain, 29006
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07198
Novo Nordisk Investigational Site
Pontevedra, Spain, 36071
Novo Nordisk Investigational Site
Sevilla, Spain, 41003
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Valencia, Spain, 46014
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Taiwan
Novo Nordisk Investigational Site
Kaohsiung City, Taiwan, 833
Novo Nordisk Investigational Site
Taichung City, Taiwan, 407
Novo Nordisk Investigational Site
Tainan city, Taiwan, 710
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Novo Nordisk Investigational Site
Bangkok, Thailand, 10700
Novo Nordisk Investigational Site
Chiang Mai, Thailand, 50200
Novo Nordisk Investigational Site
Klong Luang, Pathumthani, Thailand, 12120
Novo Nordisk Investigational Site
Nakhon Ratchasima, Thailand, 30000
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06100
Novo Nordisk Investigational Site
Ankara, Turkey, 06500
Novo Nordisk Investigational Site
Antalya, Turkey, 07058
Novo Nordisk Investigational Site
Aydin, Turkey, 09010
Novo Nordisk Investigational Site
Denizli, Turkey, 20070
Novo Nordisk Investigational Site
Gaziantep, Turkey, 27070
Novo Nordisk Investigational Site
Istanbul, Turkey, 34371
Novo Nordisk Investigational Site
Istanbul, Turkey, 34760
Novo Nordisk Investigational Site
Izmir, Turkey, 35100
Novo Nordisk Investigational Site
Izmir, Turkey, 35340
Novo Nordisk Investigational Site
Rize, Turkey, 53020
United Kingdom
Novo Nordisk Investigational Site
Aberdeen, United Kingdom, AB25 2ZD
Novo Nordisk Investigational Site
Bristol, United Kingdom, BS10 5NB
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Novo Nordisk Investigational Site
Exeter, United Kingdom, EX2 5DW
Novo Nordisk Investigational Site
Guildford, United Kingdom, GU2 7XX
Novo Nordisk Investigational Site
Norfolk, United Kingdom, NR4 7UQ
Novo Nordisk Investigational Site
Swansea, United Kingdom, SA2 8PP
Novo Nordisk Investigational Site
Watford, United Kingdom, WD18 0HB
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02692716     History of Changes
Other Study ID Numbers: NN9924-4221
2015-003563-10 ( EudraCT Number )
U1111-1173-0750 ( Other Identifier: WHO )
NL56580.091.16 ( Other Identifier: CCMO )
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases