Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT02863419
Last Updated: 2022-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
711 participants
INTERVENTIONAL
2016-08-10
2018-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oral Semaglutide
semaglutide
Oral semaglutide once-daily.
Liraglutide
liraglutide
Subcutaneous (s.c.) injection once-daily.
Placebo
placebo
Placebo once-daily.
Interventions
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semaglutide
Oral semaglutide once-daily.
liraglutide
Subcutaneous (s.c.) injection once-daily.
placebo
Placebo once-daily.
Eligibility Criteria
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Inclusion Criteria
* Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age at least 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening.
* HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)
* Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with a stable daily dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days prior to day of screening (fixed-dose combinations are allowed)
* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
* History of diabetic ketoacidosis
Exclusion Criteria
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* 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 and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)
* Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
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Los Alamitos, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Hallandale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Peoria, Illinois, United States
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Topeka, Kansas, United States
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Slidell, Louisiana, United States
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Butte, Montana, United States
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Lebanon, New Hampshire, United States
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Teaneck, New Jersey, United States
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Albany, New York, United States
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Mineola, New York, United States
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Greensboro, North Carolina, United States
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Morganton, North Carolina, United States
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Wilmington, North Carolina, United States
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Dublin, Ohio, United States
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Maumee, Ohio, United States
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Norman, Oklahoma, United States
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McMurray, Pennsylvania, United States
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Summerville, South Carolina, United States
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Bristol, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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North Richland Hills, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Karlovac, , Croatia
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Osijek, , Croatia
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Slavonski Brod, , Croatia
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Zagreb, , Croatia
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Zagreb, , Croatia
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Náchod, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Bochum, , Germany
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Duisburg, , Germany
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Falkensee, , Germany
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Hamburg, , Germany
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Ludwigshafen, , Germany
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Oldenburg I. Holst, , Germany
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Saint Ingbert-Oberwürzbach, , Germany
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Villingen-Schwenningen, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Kalocsa, , Hungary
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Nagykanizsa, , Hungary
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Szeged, , Hungary
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Székesfehérvár, , Hungary
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Szigetvár, , Hungary
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Szolnok, , Hungary
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Tatabánya, , Hungary
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Bunkyo-ku, Tokyo, , Japan
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Kumamoto-shi,Kumamoto, , Japan
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Mito-shi, Ibaraki, , Japan
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Okawa-shi, Fukuoka, , Japan
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Sapporo-shi, Hokkaido, , Japan
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Shimotsuke-shi, Tochigi, , Japan
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Suita-shi, Osaka, , Japan
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Tochigi, , Japan
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Yamato-shi, Kanagawa, , Japan
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Ogre, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gniewkowo, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Toa Baja, , Puerto Rico
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Rožňava, , Slovakia
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Vrútky, , Slovakia
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Benoni, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
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Ajman, , United Arab Emirates
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Al Mafraq, , United Arab Emirates
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Dubai, , United Arab Emirates
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Rahba City, , United Arab Emirates
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Umm Al Quwain City, , United Arab Emirates
Countries
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References
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Pratley R, Amod A, Hoff ST, Kadowaki T, Lingvay I, Nauck M, Pedersen KB, Saugstrup T, Meier JJ; PIONEER 4 investigators. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Lancet. 2019 Jul 6;394(10192):39-50. doi: 10.1016/S0140-6736(19)31271-1. Epub 2019 Jun 8.
Araki E, Terauchi Y, Watada H, Deenadayalan S, Christiansen E, Horio H, Kadowaki T. Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials. Diabetes Obes Metab. 2021 Dec;23(12):2785-2794. doi: 10.1111/dom.14536. Epub 2021 Sep 27.
Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9.
Ren H, Berry S, Malkin SJP, Hunt B, Bain S. Early use of oral semaglutide in the UK: A cost-effectiveness analysis versus continuing metformin and SGLT-2 inhibitor therapy. BMJ Open. 2023 Sep 29;13(9):e070473. doi: 10.1136/bmjopen-2022-070473.
Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.
Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.
Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2015-005210-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1176-6029
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-4224
Identifier Type: -
Identifier Source: org_study_id
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