A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes
NCT ID: NCT04017832
Last Updated: 2024-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1441 participants
INTERVENTIONAL
2019-07-29
2021-10-27
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
QUADRUPLE
Study Groups
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Oral semaglutide 3 mg and placebo (sitagliptin)
Oral semaglutide tablets 3 mg and sitagliptin placebo tablets for 26 weeks
Oral semaglutide
Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
Placebo (sitagliptin)
Placebo tablet to be taken 30 minutes after oral semaglutide
Oral semaglutide 7 mg and placebo (sitagliptin)
Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 4 weeks, after which the target dose of 7 mg is taken for 22 weeks
Oral semaglutide
Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
Placebo (sitagliptin)
Placebo tablet to be taken 30 minutes after oral semaglutide
Oral semaglutide 14 mg and placebo (sitagliptin)
Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 8 weeks, after which the target dose of 14 mg is taken for 18 weeks
Oral semaglutide
Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
Placebo (sitagliptin)
Placebo tablet to be taken 30 minutes after oral semaglutide
Sitagliptin 100 mg and placebo (oral semaglutide)
Sitagliptin tablets and oral semaglutide placebo tablets for 26 weeks
Sitagliptin
Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets
Placebo (oral semaglutide)
Placebo tablet to be taken first thing in the morning
Interventions
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Oral semaglutide
Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
Sitagliptin
Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets
Placebo (oral semaglutide)
Placebo tablet to be taken first thing in the morning
Placebo (sitagliptin)
Placebo tablet to be taken 30 minutes after oral semaglutide
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 Algeria only: Male or female, age above or equal to 19 years at the time of signing informed consent.
For Taiwan only: Male or female, age above or equal to 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus 60 days or more prior to day of screening.
* HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive).
* Stable daily dose of metformin (equal to or above 1500 mg or maximum tolerated dose as documented in the subject medical record) 60 days or more prior to day of screening
Exclusion Criteria
* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.
* History or presence 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).
* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation.
* 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.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
* Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN).
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Fundus examination without dilation is only allowed if the digital camera used for fundus photography has this feature.
* Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
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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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Maison des diabétiques El Harrach
Algiers, , Algeria
Department of internal medicine hospital (CHU) of BIRTRARIA
Algiers, , Algeria
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, Brazil
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Second Affliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
900th Hospital of Joint Logistics Support Force
Fuzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
The 2nd Affiliated Hospital of Shantou Uni Medical College
Shantou, Guangdong, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Harrison International Peace Hospital
Hengshui, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The First Affiliated Hospital of Henan university of Science
Luoyang, Henan, China
Zhengzhou First People's Hospital
Zhengzhou, Henan, China
Taihe Hospital
Shiyan, Hubei, China
Wuhan Puai Hosptial
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
Chenzhou No.1 People's Hospital
Chenzhou, Hunan, China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Jilin Province People's Hospital
Changchun, Jilin, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
The second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China
The Affiliated Hospital of Qingdao Medical College
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai Pudong New Area People's Hospital
Pudong New District, Shanghai Municipality, China
Shanghai Huashan Hospital, Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Tongji Hospital of Tongji university
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hsopital, Tongji University
Shanghai, Shanghai Municipality, China
Dongfang Hospital Affiliated to Shanghai Tongji University
Shanghai, Shanghai Municipality, China
The Fifth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
Shanghai, Shanghai Municipality, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
First Affiated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The 2nd Affi Hosp of Zhejiang Univer School of Medicine
Hangzhou, Zhejiang, China
The Third Xiangya Hospital of Central South University
Changsha, , China
Nemocnice milosrdnych bratri
Brno, , Czechia
DIAMIN
Chrudim, , Czechia
Interna a diabetologie MUDr. Vodickova
Liberec, , Czechia
CCR Prague
Prague, , Czechia
MUDr. Michala Pelikanova
Prague, , Czechia
Prince of Wales Hospital
Shatin, New Territories, , Hong Kong
SC Grand Med SRL
Oradea, Bihor County, Romania
S.C. Endodigest S.R.L.
Oradea, Bihor County, Romania
SC Centru Medical Dr. Negrisanu SRL
Timișoara, Timiș County, Romania
SC Nutrilife SRL
Bucharest, , Romania
Clinic of Diabetes Constanta
Constanța, , Romania
Clinical County Emergency Hosp
Oradea, , Romania
Clinical Hospital Centre Dragisa Misovic
Belgrade, , Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, , Serbia
Clinical Hospital Centre Zemun
Belgrade, , Serbia
GCT
Arcadia, Gauteng, South Africa
Dr R Dulabh
Johannesburg, Gauteng, South Africa
Newtown Clinical Research
Johannesburg, Gauteng, South Africa
WITS Clinical Research
Johannesburg, Gauteng, South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, South Africa
Setshaba Research Centre
Soshanguve, Gauteng, South Africa
Armansis Medical Centre
Brits, North West, South Africa
Cape Town Medical Research Centre
Kuilsriver, Western Cape, South Africa
Paarl Reserch Centre
Paarl, Western Cape, South Africa
Union Hospital
Alberton, , South Africa
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linko Branch
Taoyuan, , Taiwan
Countries
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References
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Ji L, Agesen RM, Bain SC, Fu F, Gabery S, Geng J, Li Y, Lu Y, Luo B, Pang W, Tao Y; PIONEER 12 investigators. Efficacy and safety of oral semaglutide vs sitagliptin in a predominantly Chinese population with type 2 diabetes uncontrolled with metformin: PIONEER 12, a double-blind, Phase IIIa, randomised trial. Diabetologia. 2024 Sep;67(9):1800-1816. doi: 10.1007/s00125-024-06133-4. Epub 2024 Jul 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1188-1256
Identifier Type: OTHER
Identifier Source: secondary_id
2018-002589-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9924-4309
Identifier Type: -
Identifier Source: org_study_id
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