Clinical trial NCT04707469: Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
Official title: Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 1606
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.


Eligibility criteria: Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
* HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
* BMI equal to or above 25 kg/m\^2
* Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
* No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \*:

  * Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
  * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
  * Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
* Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
* Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).

Exclusion Criteria:

* Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
* 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.

Primary outcomes:
measure: Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
timeFrame: Baseline (week 0), week 52
Secondary outcomes:
measure: Change From Baseline in Body Weight (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline in HbA1c (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Change From Week 12 in HbA1c (Week 52)
timeFrame: Week 12, Week 52
measure: Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline in FPG (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)
timeFrame: At week 52
measure: Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)
timeFrame: At week 68
measure: Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)
timeFrame: At week 52
measure: Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)
timeFrame: At week 68
measure: Time to Event Analyses of Rescue Medication
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline in Body Weight (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Percentage Change From Baseline in Body Weight (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Percentage Change From Baseline in Body Weight (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Percentage Change From Week 12 in Body Weight (Week 52)
timeFrame: Week 12, Week 52
measure: Change From Baseline in Body Mass Index (BMI) (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline in BMI (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline in Waist Circumference (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline in Waist Circumference (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)
timeFrame: At week 52
measure: Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)
timeFrame: At week 68
measure: Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)
timeFrame: At week 52
measure: Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)
timeFrame: At week 68
measure: Change From Baseline in Total Cholesterol (Week 52)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Total Cholesterol (Week 68)
timeFrame: Baseline, Week 68
measure: Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)
timeFrame: Baseline, Week 52
measure: Change From Baseline in LDL (Week 68)
timeFrame: Baseline, Week 68
measure: Change From Baseline in High Density Lipoproteins (HDL) (Week 52)
timeFrame: Baseline, Week 52
measure: Change From Baseline in HDL (Week 68)
timeFrame: Baseline, Week 68
measure: Change From Baseline in Triglycerides (Week 52)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Triglycerides (Week 68)
timeFrame: Baseline, Week 68
measure: Number of Adverse Events
timeFrame: From baseline (week 0) up to week 73
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)
timeFrame: From baseline (week 0) up to week 68
measure: Change From Baseline in Systolic Blood Pressure (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline in Systolic Blood Pressure (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline in Diastolic Blood Pressure (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline in Diastolic Blood Pressure (Week 68)
timeFrame: Baseline (week 0), week 68
measure: Change From Baseline in Pulse (Week 52)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline in Pulse (Week 68)
timeFrame: Baseline (week 0), week 68
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: American Clinical Trials
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: La Mesa
country: United States
facility: Velocity Clin Res San Diego
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Los Alamitos
country: United States
facility: Pacific Clinical Studies
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Wstlke
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: Poway
country: United States
facility: Gateway Research Center
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research_Spring Valley
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: West Hills
country: United States
facility: San Fernando Valley Hlth Inst
state: California
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Jacksonville
country: United States
facility: Northeast Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Res Clin Miami Lakes
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research
state: Florida
city: Roswell
country: United States
facility: Endo Res Solutions Inc
state: Georgia
city: Honolulu
country: United States
facility: East West Med Res Inst
state: Hawaii
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Gillespie
country: United States
facility: Macoupin Research Group
state: Illinois
city: Skokie
country: United States
facility: Evanston Premier Hlthcr Res
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Inst For Clin Res
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diab & Endo Res Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clin Research Ctr
state: Kansas
city: Lexington
country: United States
facility: The Research Group of Lexington LLC
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Waltham
country: United States
facility: MassResearch, LLC
state: Massachusetts
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare, PLC.
state: Michigan
city: Butte
country: United States
facility: Mercury Str Med Grp, PLLC
state: Montana
city: Trenton
country: United States
facility: Premier Research Inc.
state: New Jersey
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Mason
country: United States
facility: Albert J Weisbrot
state: Ohio
city: Norman
country: United States
facility: Intend Research
state: Oklahoma
city: Corvallis
country: United States
facility: Corvallis Clinic PC Clinical Research Department
state: Oregon
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians_Pittsburgh
state: Pennsylvania
city: Bristol
country: United States
facility: Holston Medical Group Pc
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Arlington
country: United States
facility: Arlington Family Res. Ctr Inc
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Med Cntr
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC_Houston
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Plano
country: United States
facility: Research Institute Of Dallas
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Norfolk
country: United States
facility: York Clinical Research LLC
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates
state: Virginia
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Milton
country: Australia
facility: Core Research Centre
state: Queensland
city: Keswick
country: Australia
facility: South Australian Endocrine Research
state: South Australia
city: Oaklands Park
country: Australia
facility: Southern Adelaide Diabetes & Endocrine Services
state: South Australia
city: Geelong
country: Australia
facility: Barwon Health (The Geelong Hospital)
state: Victoria
city: Blagoevgrad
country: Bulgaria
facility: "MHAT-Blagoevgrad", Department of Internal Diseases
city: Lom
country: Bulgaria
facility: Medical Center Zdrave Lom
city: Pazardzhik
country: Bulgaria
facility: UMHAT Pulmed, Department of endocrinology
city: Pazardzhik
country: Bulgaria
facility: "MHAT - Pazardzhik"
city: Pleven
country: Bulgaria
facility: OCSOMCE - Dr. Albena Dinkova EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
city: Plovdiv
country: Bulgaria
facility: 'MHAT Sveta Karidad' EAD
city: Sliven
country: Bulgaria
facility: 'MHAT Hadzhi Dimitar' OOD
city: Smolyan
country: Bulgaria
facility: "Medical center Smolyan clinical research" OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Aleksandrovska"
city: Sofia
country: Bulgaria
facility: USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
city: Sofia
country: Bulgaria
facility: Medical Institute of Ministry of interior
city: Varna
country: Bulgaria
facility: UMHAT Sveta Marina EAD
city: Varna
country: Bulgaria
facility: AIPSMC Dr. Artin Magardichyan EOOD
city: Vratsa
country: Bulgaria
facility: MHAT- Hristo Botev
city: Yambol
country: Bulgaria
facility: "MHAT "Sveti Panteleimon" - Yambol" AD
city: Calgary
country: Canada
facility: LMC Clin Res Inc. Calgary
state: Alberta
city: Calgary
country: Canada
facility: C-endo Diab Endo Clin Calgery
state: Alberta
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Brampton
country: Canada
facility: LMC ClinRsrh Inc.Brampton
state: Ontario
city: Concord
country: Canada
facility: LMC Clinical Res Thornhill
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Endo Ctr (Etobicoke) Ltd
state: Ontario
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Nepean
country: Canada
facility: LMC Research Inc. Ottawa
state: Ontario
city: Oakville
country: Canada
facility: LMC Oakville
state: Ontario
city: Stoney Creek
country: Canada
facility: Winterberry Family Medicine
state: Ontario
city: Toronto
country: Canada
facility: LMC Endo Centres Ltd.(Bayview)
state: Ontario
city: Montreal
country: Canada
facility: Applied Med Inf Res
state: Quebec
city: Saint-Laurent
country: Canada
facility: LMC Clin Rsrch Inc. (Montreal)
state: Quebec
city: Zagreb
country: Croatia
facility: Poliklinika Solmed
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: KBC Rijeka, Endokrinologija
state: Primorsko - Goranska Županija
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek
city: Slavonski Brod
country: Croatia
facility: Opca bolnica Dr. Josip Bencevic
city: Zagreb
country: Croatia
facility: KB Dubrava, Zavod za endokrinologiju i dijabetes
city: Zagreb
country: Croatia
facility: Klinicka bolnica Sveti Duh
city: Chomutov
country: Czechia
facility: Ordinace pro choroby srdce
city: Holešov
country: Czechia
facility: Diahaza s.r.o.
city: Plzeň 3
country: Czechia
facility: DIALINE s.r.o.
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha
country: Czechia
facility: Diabetologická a endokrinologická ambulance Praha
city: Pärnu
country: Estonia
facility: Private Endocrnologist Dr Viitas
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Centre
city: Tallinn
country: Estonia
facility: Estonian Diabetes Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital Internal Medicine Clinic
city: Berlin
country: Germany
facility: Institut für Klinische Forschung und Entwicklung
city: Essen
country: Germany
facility: Plassmann
city: Falkensee
country: Germany
facility: Zentrum für klinische Forschung, Dr. med. Lüdemann
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut für medizinische Forschung und Fortbildung GmbH
city: Rehlingen-Siersburg
country: Germany
facility: Praxis Dr. med. Wenzl-Bauer
city: Pécs
country: Hungary
facility: PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
state: Baranya Vármegye
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet
state: Komárom-Esztergom
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Budapest
country: Hungary
facility: Szőcs Depot Egészségügyi Szolgáltató Kft.
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Oktatókórház
city: Guntur
country: India
facility: Endolife Specialty Hospitals
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Care Outpatient Centre
state: Andhra Pradesh
city: New Delhi
country: India
facility: Fortis Hospital, Shalimar Bagh, New Delhi
state: Delhi
city: Surat
country: India
facility: Nirmal Hospital Pvt. Ltd.
state: Gujarat
city: Rohtak
country: India
facility: PGIMS Rohtak
state: Haryana
city: Belgaum
country: India
facility: KLES & Prabhakar Kore Hospital and Research Centre
state: Karnatka
city: Kochi
country: India
facility: Amrita Institute Of Medical Sciences & Research Centre
state: Kerala
city: Mumbai
country: India
facility: Seth GS medical college and KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Inamdar Multispeciality Hospital
state: Maharashtra
city: Delhi
country: India
facility: Apollo Hospital
state: New Delhi
city: New Dehli
country: India
facility: All India Institute of Medical Sciences
state: New Delhi
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
state: Punjab
city: Vellore
country: India
facility: Christian Medical College Hospital, Vellore
state: Tamil Nadu
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Hyderabad
country: India
facility: Gandhi Hospital & Medical college
state: Telengana
city: Hyderabad
country: India
facility: Gleneagles Hospitals
state: Telengana
city: Lucknow
country: India
facility: MV Hospital and Research Centre
state: Uttar Pradesh
city: Kolkata
country: India
facility: I.P.G.M.E & R Hospital
state: West Bengal
city: Kolkata
country: India
facility: Apollo Multispeciality Hospital, Kolkata
state: West Bengal
city: Lublin
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Medica
state: Lubelski
city: Gorzow Wielkopolski
country: Poland
facility: Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
state: Lubuskie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
state: Podlaskie
city: Bialystok
country: Poland
facility: Kresmed Sp. z o. o.
state: Podlaskie
city: Poznan
country: Poland
facility: Centrum Zdrowia Metabolicznego
state: Wielkopolskie Voivodeship
city: Bialystok
country: Poland
facility: Osteo Medic s.c. Artur Racewicz Jerzy Supronik
city: Bialystok
country: Poland
facility: SNZOZ Lege Artis
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House
city: Krakow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital w Krakowie
city: Lodz
country: Poland
facility: Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
city: Poznan
country: Poland
facility: Gaja Poradnie Lekarskie
city: Radom
country: Poland
facility: Centrum Medyczne "Diabetika"
city: Warszawa
country: Poland
facility: NBR Polska Tomasz Klodawski
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Zabrze
country: Poland
facility: Prywatny Gabinet Janusz Gumprecht
city: Manati
country: Puerto Rico
facility: Manati Ctr For Clin Research
city: Bardejov
country: Slovakia
facility: DIADA, s.r.o.
city: Hnusta
country: Slovakia
facility: Diabetologicka ambulancia Diabetes care, s.r.o.
city: Kezmarok
country: Slovakia
facility: Diabetologicka ambulancia DIAMO s.r.o.
city: Kralovsky Chlmec
country: Slovakia
facility: MOMED, s.r.o
city: Lucenec
country: Slovakia
facility: IN-DIA s.r.o.
city: Presov
country: Slovakia
facility: DIABETOL, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: OLIVER - MED s.r.o.
city: Sabinov
country: Slovakia
facility: MEDI-DIA s.r.o.
city: Spisska Nova Ves
country: Slovakia
facility: Diabetologicka ambulancia MUDr. Gabriela Zimova
city: Celje
country: Slovenia
facility: General Hospital Celje
city: Koper
country: Slovenia
facility: Healthcare Centre Koper
city: Ljubljana
country: Slovenia
facility: UKC Ljubljana, Endocrinology and Diabetes
city: Maribor
country: Slovenia
facility: UKC Maribor - diabetes
city: Nova Gorica
country: Slovenia
facility: Healtcare Centre Nova Gorica
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: Aroda VR, Aberle J, Bardtrum L, Christiansen E, Knop FK, Gabery S, Pedersen SD, Buse JB. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. Lancet. 2023 Aug 26;402(10403):693-704. doi: 10.1016/S0140-6736(23)01127-3. Epub 2023 Jun 26.