A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes
PIONEER 12
China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
3 other identifiers
interventional
1,441
9 countries
93
Brief Summary
This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Jul 2019
Typical duration for phase_3 diabetes-mellitus-type-2
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
July 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2021
CompletedResults Posted
Study results publicly available
September 29, 2023
CompletedOctober 1, 2024
September 1, 2024
2.2 years
July 11, 2019
October 26, 2022
September 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)
Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication.
From baseline to week 26
Secondary Outcomes (43)
Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)
From baseline to week 26
Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile
From baseline to week 26
Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)
From baseline to week 26
Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)
At week 26
Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)
At week 26
- +38 more secondary outcomes
Study Arms (4)
Oral semaglutide 3 mg and placebo (sitagliptin)
EXPERIMENTALOral semaglutide tablets 3 mg and sitagliptin placebo tablets for 26 weeks
Oral semaglutide 7 mg and placebo (sitagliptin)
EXPERIMENTALOral 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 14 mg and placebo (sitagliptin)
EXPERIMENTALOral 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
Sitagliptin 100 mg and placebo (oral semaglutide)
EXPERIMENTALSitagliptin tablets and oral semaglutide placebo tablets for 26 weeks
Interventions
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 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 tablet to be taken first thing in the morning
Placebo tablet to be taken 30 minutes after oral semaglutide
Eligibility Criteria
You may qualify if:
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- 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
You may not qualify if:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measure as required by local regulation or practice).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (93)
Maison des diabétiques El Harrach
Algiers, 16000, Algeria
Department of internal medicine hospital (CHU) of BIRTRARIA
Algiers, 16003, Algeria
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, 01228-200, Brazil
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230061, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, 101200, China
Second Affliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
900th Hospital of Joint Logistics Support Force
Fuzhou, Fujian, 350025, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, 528399, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy
Guangzhou, Guangdong, 510120, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 511400, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001, China
The 2nd Affiliated Hospital of Shantou Uni Medical College
Shantou, Guangdong, 515065, China
Cangzhou People's Hospital
Cangzhou, Hebei, 061000, China
Harrison International Peace Hospital
Hengshui, Hebei, 053000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000, China
The First Affiliated Hospital of Henan university of Science
Luoyang, Henan, 471003, China
Zhengzhou First People's Hospital
Zhengzhou, Henan, 450004, China
Taihe Hospital
Shiyan, Hubei, 442008, China
Wuhan Puai Hosptial
Wuhan, Hubei, 430034, China
Changsha Central Hospital
Changsha, Hunan, 410018, China
Chenzhou No.1 People's Hospital
Chenzhou, Hunan, 423000, China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, 421001, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, 213003, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211106, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, Jiangsu, 211166, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Jilin Province People's Hospital
Changchun, Jilin, 130021, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007, China
The second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, 250013, China
The Affiliated Hospital of Qingdao Medical College
Qingdao, Shandong, 266003, China
Weifang People's Hospital
Weifang, Shandong, 261041, China
Shanghai Pudong New Area People's Hospital
Pudong New District, Shanghai Municipality, 201200, China
Shanghai Huashan Hospital, Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Tongji Hospital of Tongji university
Shanghai, Shanghai Municipality, 200065, China
Shanghai Tenth People's Hsopital, Tongji University
Shanghai, Shanghai Municipality, 200072, China
Dongfang Hospital Affiliated to Shanghai Tongji University
Shanghai, Shanghai Municipality, 200120, China
The Fifth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200240, China
Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
Shanghai, Shanghai Municipality, 200336, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
First Affiated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
The 2nd Affi Hosp of Zhejiang Univer School of Medicine
Hangzhou, Zhejiang, 310009, China
The Third Xiangya Hospital of Central South University
Changsha, 410013, China
Nemocnice milosrdnych bratri
Brno, 63900, Czechia
DIAMIN
Chrudim, 537 01, Czechia
Interna a diabetologie MUDr. Vodickova
Liberec, 46001, Czechia
CCR Prague
Prague, 130 00, Czechia
MUDr. Michala Pelikanova
Prague, 140 00, Czechia
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
SC Grand Med SRL
Oradea, Bihor County, 410025, Romania
S.C. Endodigest S.R.L.
Oradea, Bihor County, 410151, Romania
SC Centru Medical Dr. Negrisanu SRL
Timișoara, Timiș County, 300456, Romania
SC Nutrilife SRL
Bucharest, 13682, Romania
Clinic of Diabetes Constanta
Constanța, 900591, Romania
Clinical County Emergency Hosp
Oradea, 410169, Romania
Clinical Hospital Centre Dragisa Misovic
Belgrade, 11000, Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000, Serbia
Clinical Hospital Centre Zemun
Belgrade, 11080, Serbia
GCT
Arcadia, Gauteng, 0083, South Africa
Dr R Dulabh
Johannesburg, Gauteng, 1812, South Africa
Newtown Clinical Research
Johannesburg, Gauteng, 2001, South Africa
WITS Clinical Research
Johannesburg, Gauteng, 2193, South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, 1619, South Africa
Setshaba Research Centre
Soshanguve, Gauteng, 0152, South Africa
Armansis Medical Centre
Brits, North West, 0250, South Africa
Cape Town Medical Research Centre
Kuilsriver, Western Cape, 7580, South Africa
Paarl Reserch Centre
Paarl, Western Cape, 7646, South Africa
Union Hospital
Alberton, 1449, South Africa
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Medical Foundation - Linko Branch
Taoyuan, 333, Taiwan
Related Publications (1)
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.
PMID: 38985161DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Reporting Anchor and Disclosure (2834)
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2019
First Posted
July 12, 2019
Study Start
July 29, 2019
Primary Completion
October 27, 2021
Study Completion
October 27, 2021
Last Updated
October 1, 2024
Results First Posted
September 29, 2023
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com