A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
NCT ID: NCT05352815
Last Updated: 2025-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1291 participants
INTERVENTIONAL
2022-06-01
2024-04-23
Brief Summary
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The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec.
Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe.
Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach.
The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IcoSema
IcoSema
Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Insulin icodec
Insulin icodec
Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Interventions
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IcoSema
Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Insulin icodec
Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
4. Treated with once daily or twice daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20- 80 units/day for 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening:
* Metformin
* Sulfonylureas (a)
* Meglitinides (glinides) (a)
* DPP 4 inhibitors (a)
* Sodium glucose co transporter 2 inhibitors
* Alpha glucosidase inhibitors
* Thiazolidinediones
* Marketed oral combination products only including the products listed above.
5. Body mass index (BMI) below or equal to 40.0 kg/m\^2. (a) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation.
4. Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening.
5. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
7. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
9. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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.
Exclusion Criteria
2. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
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 Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Endeavor Health
Skokie, Illinois, United States
Seoul Saint Mary's Hospital
Seoul, , South Korea
Pri Med Grp dba/Gil Ctr Fam
Gilbert, Arizona, United States
Lenzmeier Fam Med CCT Research
Glendale, Arizona, United States
Phoenician Centers for Research & Innovation PCRI
Phoenix, Arizona, United States
Medical Investigations, Inc.
Little Rock, Arkansas, United States
John Muir Physicians Network
Concord, California, United States
Headlands Research California, LLC
Escondido, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Downtown LA Res Ctr. Inc.
Los Angeles, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Clinical Trials Research_Sacramento_0
Sacramento, California, United States
San Diego Family Care
San Diego, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
Clinical Res Of W Florida Inc
Clearwater, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
University of Miami
Miami, Florida, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, United States
Clinical Neuroscience Solution
Orlando, Florida, United States
Florida Inst For Clin Res
Orlando, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Javara/Privia Med Grp GA,LLC
Albany, Georgia, United States
Emory University SOM
Atlanta, Georgia, United States
Javara Inc.
Fayetteville, Georgia, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Saltzer Medical Group Research
Nampa, Idaho, United States
UnityPoint Health-Diabetes Care Center
Peoria, Illinois, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
The Research Group of Lexington LLC
Lexington, Kentucky, United States
Barnum Medical Research Inc.
Natchitoches, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
Ileana J Tandron APMC
Slidell, Louisiana, United States
MedStar Hlth Res Institute
Hyattsville, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
MassResearch, LLC
Waltham, Massachusetts, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
Elite Research Center
Flint, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Jefferson City Medical Group, PC
Jefferson City, Missouri, United States
Methodist Phys. Clinic
Omaha, Nebraska, United States
University of NE Med Ctr
Omaha, Nebraska, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Palm Research Center Inc.
Las Vegas, Nevada, United States
Southern New Hampshire Diabete
Nashua, New Hampshire, United States
John J Shelmet, MD
Lawrenceville, New Jersey, United States
Albuquerque Clin Trials, Inc.
Albuquerque, New Mexico, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Javara Inc. / Tryon Medical Partners PLLC
Charlotte, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Central Ohio Clinical Research LLC
Columbus, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
New Venture Medical Research
Wadsworth, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Care Access
Warwick, Rhode Island, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Athens Medical Group
Athens, Tennessee, United States
AM Diabetes And Endocrinology Center
Bartlett, Tennessee, United States
Holston Medical Group_Bristol
Bristol, Tennessee, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Univ Diab & Endo Consultants
Chattanooga, Tennessee, United States
HealthStar Physicians PC
Morristown, Tennessee, United States
Amarillo Med Spec LLP
Amarillo, Texas, United States
Texas Diabetes & Endocrinology, P.A._Austin
Austin, Texas, United States
Texas Diabetes & Endocrinology, P.A._Austin
Austin, Texas, United States
Osvaldo A. Brusco MD PA
Corpus Christi, Texas, United States
Cedar Research
Dallas, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Univ of TX SW Med Ctr Dallas
Dallas, Texas, United States
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
Javara Inc. / Privia Medical Group Gulf Coast PLLC
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Protenium Clinical Research
Hurst, Texas, United States
Medical Colleagues-Texas LLP
Katy, Texas, United States
Andres Garcia-Zuniga, MD, P.A
Laredo, Texas, United States
Milton Haber, M.D.
Laredo, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Clinical Investigations Of Texas
Plano, Texas, United States
Texas Diabetes &Endocrinology
Round Rock, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Briggs Clinical Research, LLC
San Antonio, Texas, United States
Audie L. Murphy VA Hospital
San Antonio, Texas, United States
Diabetes & Gladular Disease Research A Cetero Research Co
San Antonio, Texas, United States
Diabetes Glandular Diseases Clinic
San Antonio, Texas, United States
Javara Inc Privia Grp Gulf Cst
San Marcos, Texas, United States
SimCare, PLLC
Sugar Land, Texas, United States
Sugar Lakes Family Practice PA
Sugar Land, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Javara Inc. / Privia Medical Group LLC_Appomattox
Appomattox, Virginia, United States
Javara Inc/Privia Md GpLLC Fst
Forest, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Amherst Family Practice P.C.
Winchester, Virginia, United States
Sound Medical Research
Port Orchard, Washington, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States
The Canberra Hospital_Garran
Garran, Australian Capital Territory, Australia
Holdsworth House Clinical Research
Darlinghurst, New South Wales, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia
Novatrials
Kotara, New South Wales, Australia
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Barwon Health (The Geelong Hospital)
Geelong, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden, , Belgium
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
Brussels, , Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, , Belgium
AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
Kortrijk, , Belgium
CHU Tivoli
La Louvière, , Belgium
UZ Leuven - Endocrinology
Leuven, , Belgium
IPSMC - Dr. Nikolay Kostadinov EOOD
Burgas, , Bulgaria
Medical center Medi City 21 OOD
Kyustendil, , Bulgaria
DCC I- Pleven EOOD Endocrinology
Pleven, , Bulgaria
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, , Bulgaria
MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases
Sofia, , Bulgaria
Anhui Provincial Hospital-Endocrinology
Hefei, Anhui, China
Peking University People's Hospital-Endocrinology
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong, China
Harrison International Peace Hospital
Hengshui, Hebei, China
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
Hengshui, Hebei, China
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, 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-Endocrinology
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University-Endocrinology
Suzhou, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China
Shanghai Fifth People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, China
General Hospital of Tianjin Medical University-Endocrinology
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Poliklinika Solmed
Zagreb, City of Zagreb, Croatia
Poliklinika SLAVONIJA OSIJEK
Osijek, County of Osijek-Baranja, Croatia
Klinicki bolnicki centar Osijek
Osijek, , Croatia
Opca bolnica Pula
Pula, , Croatia
KBC Rijeka, Endokrinologija
Rijeka, , Croatia
Ähtärin terveysasema
Ähtäri, , Finland
Health Step Finland Oy
Kuopio, , Finland
Etelä-Savon sosiaali- ja terveyspalvelujen kuntayhtymä
Mikkeli, , Finland
Raision sosiaali- ja terveyskeskus
Raisio, , Finland
Tampereen diabetesvastaanotto
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Yashoda Hospital
Secunderabad, Andhra Pradesh, India
Apollo Excelcare Hospital
Guwahati, Assam, India
Gujarat Endocrine Centre
Ahmedabad, Gujarat, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, India
Lifecare Hospital and Research Centre
Bangalore, Karnataka, India
Mysore Medical College and Research Institute
Mysore, Karnataka, India
Government Medical College, Kozhikode
Kozhikode, Kerala, India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, Kerala, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, India
BYL Nair Hospital and T N Medical College Department of endo
Mumbai, Maharashtra, India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, India
Bhaktivedanta Hospital & Research Institute
Mumbai, Maharashtra, India
Inamdar Multispeciality Hospital
Pune, Maharashtra, India
S.C.B. Medical College
Cuttack, Odisha, India
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, India
Dayanand Medical College & Hospital_Ludhiana
Ludhiana, Punjab, India
M.V.Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, India
Arthur Asirvatham hospital,
Madurai, Tamil Nadu, India
Osmania General Hospital
Hyderabad, Telangana, India
Ramdev Rao Hospital
Hyderabad, Telangana, India
Lady Hardinge Medical College
New Delhi, , India
Sir Ganga Ram Hospital
New Delhi, , India
A.O.U. Consorziale Policlinico di Bari
Bari, BA, Italy
Pol. Uni. Campus Biomedico
Roma, RM, Italy
Policlinico Mater Domini Università di Catanzaro
Catanzaro, , Italy
ASL 4 Chiavarese
Chiavari (genova), , Italy
Ospedale Policlinico San Martino
Genova, , Italy
Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Japan, Japan
Manda Memorial Hospital_Internal Medicine
Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan
Hayashi Diabetes Clinic
Chigasaki-shi, Kanagawa, Kanagawa, Japan, Japan
Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
Chigasaki-shi, Kanagawa, Japan, Japan
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, Japan
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
Heiwadai Hospital
Miyazaki, Miyazaki, Japan
Kumanomae Nishimura Naika Clinic_Internal Medicine
Arakawa-ku, Tokyo, , Japan
Akaicho Clinic
Chiba-shi, Chiba, , Japan
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, , Japan
Futata Tetsuhiro Clinic Meinohama
Fukuoka-shi, Fukuoka, , Japan
Kunisaki Makoto Clinic
Fukuoka-shi, Fukuoka, , Japan
Sasaki Internal Medicine
Hokkaido, , Japan
Yoshimura clinic
Kumamoto, , Japan
Hisatomi Clinic
Saga-shi, Saga, , Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, , Japan
Fukuwa Clinic_Internal Medicine
Tokyo, , Japan
Yokohama City University Hospital, Endocrinology, Metabolism
Yokohama-shi, Kanagawa, , Japan
Hospital Universitario Dr. José Eleuterio González_Monterrey
Monterrey, Nuevo León, Mexico
Centro de Investigación Cardiometabólica de Aguascalientes
Aguascalientes, , Mexico
Clínicos Asociados BOCM, S.C.
Mexico City, , Mexico
Nordlandssykehuset Bodø
Bodø, , Norway
Drammen sykehus - Vestre Viken HF
Drammen, , Norway
Bærum sykehus
Gjettum, , Norway
Sykehuset Innlandet HF Hamar
Hamar, , Norway
Akershus universitetssykehus HF
Lørenskog, , Norway
Oslo universitetssykehus Aker
Oslo, , Norway
St. Olavs Hospital HF
Trondheim, , Norway
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, Poland
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, , Poland
NZOZ "CenterMed Lublin" Sp. z o.o.
Lublin, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, , Poland
Unidade Local De Saude De Matosinhos E.P.E.
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta
Almada, , Portugal
Unidade Local De Saude De Amadora Sintra E.P.E. - Hospital Prof. Dr. Fernando da Fonseca
Amadora, , Portugal
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Aveiro, , Portugal
Unidade de Local de Saúde de Braga
Braga, , Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, , Portugal
Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, , Portugal
Hospital Da Luz S.A.
Lisbon, , Portugal
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, , Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, , Portugal
Hospital Luz Arrabida, S.A.
Vila Nova de Gaia, , Portugal
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Vila Real, , Portugal
Advanced Clinical Research LLC
Bayamón, , Puerto Rico
Manati Ctr For Clin Research
Manatí, , Puerto Rico
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, Romania
CMI Diabet, Nutritie, Boli Metabolice "Dr Pop Lavinia"
Baia Mare, Maramureş, Romania
Mariodiab Clinic SRL
Brasov, , Romania
SC Consultmed SRL
Iași, , Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, , Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava, , Romania
Tumen State Medical University
Tyumen, Russia, Russia
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, , Russia
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk, , Russia
Limited Liability Company "AriVa-Med"
Kursk, , Russia
City Consultative & Diagnostic Centre #1
Saint Petersburg, , Russia
Saratov regional clinical hospital
Saratov, , Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, , Serbia
Deepak Lakha
Johannesburg, Gauteng, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, South Africa
Dr Pillay's Rooms
Durban, KwaZulu-Natal, South Africa
Armansis Medical Centre
Brits, North West, South Africa
Langeberg Clinical Trials
Cape Town, Western Cape, South Africa
Netcare Alberton Hospital
Alberton, , South Africa
Soonchunhyang University Hospital
Cheonan, Chungcheongnam-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital_Seongnam-si
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Changhua Christian Hospital_Metabolic Dept.
Changhua, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chi Mei Medical Center
Tainan, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi-Endokrinoloji
Ankara, Altindag, Turkey (Türkiye)
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji
Adana, , Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Haseki Eğitim ve Araştırma Hastanesi- Dahiliye
Istanbul, , Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, , Turkey (Türkiye)
T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye
Tekirdağ, , Turkey (Türkiye)
Countries
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References
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Mathieu C, Giorgino F, Kim SG, Larsen JH, Philis-Tsimikas A, Ramachandran A, Pagliaro Rocha TM, Shankarappa VB, Terauchi Y, Ji L. Once-weekly IcoSema versus once-weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open-label, multicentre, treat-to-target, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):568-579. doi: 10.1016/S2213-8587(25)00096-8. Epub 2025 Jun 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1260-8259
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005281-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1535-4591
Identifier Type: -
Identifier Source: org_study_id
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