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 (COMBINE 1)

November 27, 2025 updated by: Novo Nordisk A/S

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1291

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital_Garran
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Clinical Research
      • Darlinghurst, New South Wales, Australia, 2010
        • Momentum Clinical Research Darlinghurst
      • Kotara, New South Wales, Australia, 2289
        • Novatrials
      • Wollongong, New South Wales, Australia, 2500
        • Illawarra Diabetes Service Clinical Trials & Research Unit
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine services
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Barwon Health (The Geelong Hospital)
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis - Bonheiden - Department of Endocrinology
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
      • Brussels, Belgium, 1090
        • UZ Brussel - Universitair Ziekenhuis Brussel
      • Edegem, Belgium, 2650
        • UZA - UZ Antwerpen - Department of Endocrinology
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
      • La Louvière, Belgium, 7100
        • CHU Tivoli
      • Leuven, Belgium, 3000
        • UZ Leuven - Endocrinology
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • IPSMC - Dr. Nikolay Kostadinov EOOD
      • Kyustendil, Bulgaria, 2500
        • Medical center Medi City 21 OOD
      • Pleven, Bulgaria, 5801
        • DCC I- Pleven EOOD Endocrinology
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
      • Sofia, Bulgaria, 1606
        • MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital-Endocrinology
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital-Endocrinology
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Chongqing University Three Gorges Hospital
    • Guangdong
      • Huizhou, Guangdong, China, 516001
        • Huizhou Central People's Hospital-Endocrinology
    • Hebei
      • Hengshui, Hebei, China, 053000
        • Harrison International Peace Hospital
      • Hengshui, Hebei, China, 053000
        • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
    • Henan
      • Kaifeng, Henan, China, 475000
        • Huaihe Hospital of Henan University-Endocrinology
    • Jiangsu
      • Changzhou, Jiangsu, China, 213004
        • The First People's Hospital of Changzhou
      • Changzhou, Jiangsu, China, 213003
        • Changzhou No.2 People's Hospital, Yanghu Branch
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University_Nanjing
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University-Endocrinology
      • Zhenjiang, Jiangsu, China, 212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital Affiliated to Shandong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200240
        • Shanghai Fifth People's Hospital-Endocrinology
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300211
        • The Second Hospital of Tianjin Medical University
      • Tianjin, Tianjin Municipality, China, 300052
        • General Hospital of Tianjin Medical University-Endocrinology
  • Croatia
      • Osijek, Croatia, 31 000
        • Klinicki Bolnicki Centar Osijek
      • Pula, Croatia, 52100
        • Opca bolnica Pula
      • Rijeka, Croatia, 51000
        • KBC Rijeka, Endokrinologija
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Poliklinika Solmed
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Poliklinika SLAVONIJA OSIJEK
  • Finland
      • Kuopio, Finland, 70210
        • Health Step Finland Oy
      • Mikkeli, Finland, 50100
        • Etelä-Savon sosiaali- ja terveyspalvelujen kuntayhtymä
      • Raisio, Finland, 21200
        • Raision sosiaali- ja terveyskeskus
      • Tampere, Finland, 33900
        • Tampereen diabetesvastaanotto
      • Turku, Finland, 20520
        • Turku University Hospital
      • Ähtäri, Finland, 63700
        • Ähtärin terveysasema
  • India
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110001
        • Lady Hardinge Medical College
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, India, 500003
        • Yashoda Hospital
    • Assam
      • Guwahati, Assam, India, 781033
        • Apollo Excelcare Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Gujarat Endocrine Centre
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt. Ltd.
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Lifecare Hospital and Research Centre
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Government Medical College, Kozhikode
      • Thriruvananthapuram, Kerala, India, 695 032
        • Jothydev's Diabetes & Research Center
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Kolhāpur, Maharashtra, India, 416008
        • Excel Endocrine Centre
      • Mumbai, Maharashtra, India, 400012
        • Seth GS medical college and KEM Hospital
      • Mumbai, Maharashtra, India, 400008
        • BYL Nair Hospital and T N Medical College Department of endo
      • Mumbai, Maharashtra, India, 401107
        • Bhaktivedanta Hospital & Research Institute
      • Pune, Maharashtra, India, 411040
        • Inamdar Multispeciality Hospital
    • Odisha
      • Cuttack, Odisha, India, 753007
        • S.C.B. Medical College
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Post Graduate Institute of Medical Education & Research
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College & Hospital_Ludhiana
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 013
        • M.V.Hospital for Diabetes Pvt. Ltd.
      • Madurai, Tamil Nadu, India, 625020
        • Arthur Asirvatham hospital,
    • Telangana
      • Hyderabad, Telangana, India, 500012
        • Osmania General Hospital
      • Hyderabad, Telangana, India, 500072
        • Ramdev Rao Hospital
  • Italy
      • Catanzaro, Italy, 88100
        • Policlinico Mater Domini Università di Catanzaro
      • Chiavari (genova), Italy, 16043
        • ASL 4 Chiavarese
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino
      • Milan, Italy, 20162
        • Grande Ospedale Metropolitano Niguarda
    • BA
      • Bari, BA, Italy, 70124
        • A.O.U. Consorziale Policlinico di Bari
    • RM
      • Roma, RM, Italy, 00128
        • Pol. Uni. Campus Biomedico
  • Japan
      • Arakawa-ku, Tokyo, Japan, 116-0012
        • Kumanomae Nishimura Naika Clinic_Internal Medicine
      • Chiba-shi, Chiba, Japan, 260-0804
        • Akaicho Clinic
      • Fukuoka-shi, Fukuoka, Japan, 819-0006
        • Futata Tetsuhiro Clinic Meinohama
      • Fukuoka-shi, Fukuoka, Japan, 819-0168
        • Kunisaki Makoto Clinic
      • Fukuoka-shi, Fukuoka, Japan, 819-0006
        • Futata Tetsuhiro Clinic Meinohama_Internal medicine
      • Hokkaido, Japan, 062-0007
        • Sasaki Internal Medicine
      • Kumamoto, Japan, 861-8039
        • Yoshimura Clinic
      • Saga-shi, Saga, Japan, 840-0937
        • Hisatomi Clinic
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 104-0031
        • Fukuwa Clinic_Internal Medicine
      • Yokohama-shi, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital, Endocrinology, Metabolism
    • Fukushima, Japan
      • Koriyama-shi, Fukushima, Japan, Japan, 963-8851
        • Seino Internal Medicine Clinic_Internal medicine
    • Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan, 060-0062
        • Manda Memorial Hospital_Internal Medicine
    • Kanagawa, Japan
      • Chigasaki-shi, Kanagawa, Japan, Japan, 253-0044
        • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
      • Chigasaki-shi, Kanagawa, Kanagawa, Japan, Japan, 253-0044
        • Hayashi Diabetes Clinic
    • Kumamoto, Japan
      • Kumamoto, Kumamoto, Japan, Japan, 862-0976
        • Jinnouchi Hospital_Internal Medicine
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 880-0034
        • Heiwadai Hospital_Internal Medicine
      • Miyazaki, Miyazaki, Japan, 880-0034
        • Heiwadai Hospital
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Centro de Investigación Cardiometabólica de Aguascalientes
      • Mexico City, Mexico, 03300
        • Clinicos Asociados Bocm, S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. José Eleuterio González_Monterrey
  • Norway
      • Bodø, Norway, 8005
        • Nordlandssykehuset Bodø
      • Drammen, Norway, 3004
        • Drammen sykehus - Vestre Viken HF
      • Gjettum, Norway, 1346
        • Bærum sykehus
      • Hamar, Norway, 2318
        • Sykehuset Innlandet HF Hamar
      • Lørenskog, Norway, 1478
        • Akershus Universitetssykehus HF
      • Oslo, Norway, 0586
        • Oslo Universitetssykehus Aker
      • Trondheim, Norway, NO-7030
        • St. Olavs Hospital HF
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne (UCK)
      • Lublin, Poland, 20-044
        • NZOZ "CenterMed Lublin" Sp. z o.o.
      • Warsaw, Poland, 02-507
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
    • Lubelski
      • Lublin, Lubelski, Poland, 20-538
        • NZOZ Przychodnia Specjalistyczna Medica
  • Portugal
      • Almada, Portugal, 2805-267
        • Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta
      • Amadora, Portugal, 2720-276
        • Unidade Local De Saude De Amadora Sintra E.P.E. - Hospital Prof. Dr. Fernando da Fonseca
      • Aveiro, Portugal, 3814-501
        • Unidade Local De Saude Da Regiao De Aveiro E.P.E.
      • Braga, Portugal, 4710-243
        • Unidade de Local de Saúde de Braga
      • Lisbon, Portugal, 1250-189
        • APDP - Associação Protectora dos Diabéticos de Portugal
      • Lisbon, Portugal, 1500-650
        • Hospital Da Luz S.A.
      • Lisbon, Portugal, 1349-019
        • Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
      • Matosinhos Municipality, Portugal, 4464-513
        • Unidade Local de Saúde de Matosinhos
      • Porto, Portugal, 4099-001
        • Unidade Local de Saúde de Santo António, E.P.E
      • Vila Nova de Gaia, Portugal, 4400-346
        • Hospital Luz Arrabida, S.A.
      • Vila Real, Portugal, 5000-508
        • Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
    • Matosinhos
      • Senhora Da Hora, Matosinhos, Matosinhos, Portugal, 4464-513
        • Unidade Local De Saude De Matosinhos E.P.E.
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Advanced Clinical Research LLC
      • Manatí, Puerto Rico, 00674
        • Manati Ctr For Clin Research
  • Romania
      • Brasov, Romania, 500101
        • Mariodiab Clinic SRL
      • Iași, Romania, 700547
        • SC Consultmed SRL
      • Satu Mare, Romania, 440055
        • Clinica Korall S.R.L. Satu Mare
      • Suceava, Romania, 720237
        • Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
    • Bucurestii
      • Bucharest, Bucurestii, Romania, 020475
        • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
    • Maramureş
      • Baia Mare, Maramureş, Romania, 430222
        • CMI Diabet, Nutritie, Boli Metabolice "Dr Pop Lavinia"
  • Russia
      • Arkhangelsk, Russia, 163045
        • Arkhangelsk Regional Clinical Hospital
      • Irkutsk, Russia, 664049
        • Irkutsk State Medical Academy of Postgraduate Education
      • Kursk, Russia, 305016
        • Limited Liability Company "AriVa-Med"
      • Saint Petersburg, Russia, 194354
        • City Consultative & Diagnostic Centre #1
      • Saratov, Russia, 410053
        • Saratov Regional Clinical Hospital
      • Yekaterinburg, Russia, 620102
        • Sverdlovsk Regional Clinical Hospital #1
    • Russia
      • Tyumen, Russia, Russia, 625023
        • Tumen State Medical University
  • Serbia
      • Belgrade, Serbia, 11000
        • Endocrinology, Diabetes and Metabolism Diseases Clinic
  • South Africa
      • Alberton, South Africa, 1449
        • Netcare Alberton Hospital
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1820
        • Deepak Lakha
      • Johannesburg, Gauteng, South Africa, 1827
        • Hemant Makan
      • Johannesburg, Gauteng, South Africa, 2013
        • Wits Bara Clinical Trial Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Dr Pillay's Rooms
    • North West
      • Brits, North West, South Africa, 0250
        • Armansis Medical Centre
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7572
        • Langeberg Clinical Trials
  • South Korea
      • Seongnam-si, South Korea, 463-707
        • Seoul National University Bundang Hospital_Seongnam-si
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 06591
        • Seoul Saint Mary's Hospital
      • Seoul, South Korea, 139-827
        • Nowon Eulji Medical Center, Eulji University
      • Wŏnju, South Korea, 26426
        • Wonju Severance Christian Hospital
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, South Korea, 31151
        • Soonchunhyang University Hospital
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, South Korea, 15355
        • Korea University Ansan Hospital
      • Bucheon-si, Gyeonggi-do, South Korea, 14647
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital_Metabolic Dept.
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01150
        • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji
      • Ankara, Turkey (Türkiye), 06010
        • Gulhane Egitim Arastirma Hastanesi
      • Istanbul, Turkey (Türkiye), 34899
        • T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi
      • Istanbul, Turkey (Türkiye), 34722
        • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
      • Istanbul, Turkey (Türkiye), 34098
        • Haseki Eğitim ve Araştırma Hastanesi- Dahiliye
      • Tekirdağ, Turkey (Türkiye), 59030
        • Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye
    • Altindag
      • Ankara, Altindag, Turkey (Türkiye), 06230
        • Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi-Endokrinoloji
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Pri Med Grp dba/Gil Ctr Fam
      • Glendale, Arizona, United States, 85308
        • Lenzmeier Fam Med CCT Research
      • Phoenix, Arizona, United States, 85021
        • Phoenician Centers for Research & Innovation PCRI
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Medical Investigations, Inc.
    • California
      • Concord, California, United States, 94520
        • John Muir Physicians Network
      • Escondido, California, United States, 92025
        • Headlands Research California, LLC
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • Lincoln, California, United States, 95648
        • Clinical Trials Research_Sacramento
      • Lomita, California, United States, 90717
        • Torrance Clin Res Inst, Inc.
      • Los Alamitos, California, United States, 90720
        • Pacific Clinical Studies
      • Los Angeles, California, United States, 90017
        • Downtown LA Res Ctr. Inc.
      • Los Angeles, California, United States, 90017
        • Velocity Clin Res Los Angeles
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Sacramento, California, United States, 95821
        • Clinical Trials Research_Sacramento_0
      • San Diego, California, United States, 92111
        • San Diego Family Care
      • San Ramon, California, United States, 94583
        • NorCal Endocrinology and Internal Medicine
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Denver, Colorado, United States, 80246
        • Creekside Endocrine Associates, PC
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Res Of W Florida Inc
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute
      • Miami, Florida, United States, 33136
        • University of Miami
      • Mt. Dora, Florida, United States, 32757
        • Adult Medicine of Lake County, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clin Res Port Richey
      • Orlando, Florida, United States, 32825
        • Florida Inst For Clin Res
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solution
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute Inc
    • Georgia
      • Albany, Georgia, United States, 31707
        • Javara/Privia Med Grp GA,LLC
      • Atlanta, Georgia, United States, 30303
        • Emory University SOM
      • Fayetteville, Georgia, United States, 30214
        • Javara inc.
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Assoc. LLC
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Med Res Inst
    • Idaho
      • Nampa, Idaho, United States, 83686-6011
        • Saltzer Medical Group Research
    • Illinois
      • Peoria, Illinois, United States, 61603
        • UnityPoint Health-Diabetes Care Center
      • Skokie, Illinois, United States, 60077
        • Endeavor Health
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diab & Endo Ctr
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
    • Louisiana
      • Natchitoches, Louisiana, United States, 71457
        • Barnum Medical Research Inc.
      • New Orleans, Louisiana, United States, 70119
        • New Orleans Center for Clinical Research
      • Slidell, Louisiana, United States, 70461-4231
        • Ileana J Tandron APMC
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Hlth Res Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5804
        • Brigham & Women's Hospital
      • Waltham, Massachusetts, United States, 02453
        • MassResearch, LLC
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Hlth Ctr, PC
      • Flint, Michigan, United States, 48532
        • Elite Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research LLC
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group, PC
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Phys. Clinic
      • Omaha, Nebraska, United States, 68198
        • University of NE Med Ctr
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University of Nevada School of Medicine
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc.
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Southern New Hampshire Diabete
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • John J Shelmet, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clin Trials, Inc.
    • New York
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research, PLLC
      • North Massapequa, New York, United States, 11758-1802
        • DiGiovanna Institute for Medical Education & Research
      • Smithtown, New York, United States, 11787
        • Endocrine Associates of Long Island, PC
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group, LLP
    • North Carolina
      • Charlotte, North Carolina, United States, 28287
        • Javara Inc. / Tryon Medical Partners PLLC
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences LLC
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Central Ohio Clinical Research LLC
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Wadsworth, Ohio, United States, 44281
        • New Venture Medical Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Care Access
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Athens, Tennessee, United States, 37303
        • Athens Medical Group
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes And Endocrinology Center
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group_Bristol
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research, LLC
      • Chattanooga, Tennessee, United States, 37411
        • Univ Diab & Endo Consultants
      • Morristown, Tennessee, United States, 37813
        • HealthStar Physicians PC
    • Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo Med Spec LLP
      • Austin, Texas, United States, 78731
        • Texas Diabetes & Endocrinology, P.A._Austin
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology, P.A._Austin
      • Corpus Christi, Texas, United States, 78414
        • Osvaldo A. Brusco MD PA
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75390-9302
        • Univ of TX SW Med Ctr Dallas
      • Dallas, Texas, United States, 75038
        • Cedar Research
      • Fort Worth, Texas, United States, 76132
        • Diabetes and Thyroid Ctr of FW
      • Houston, Texas, United States, 77024
        • PrimeCare Medical Group
      • Houston, Texas, United States, 77054
        • Javara Inc. / Privia Medical Group Gulf Coast PLLC
      • Houston, Texas, United States, 77079
        • PlanIt Research, PLLC
      • Hurst, Texas, United States, 76054
        • Protenium Clinical Research
      • Katy, Texas, United States, 77450
        • Medical Colleagues-Texas LLP
      • Laredo, Texas, United States, 78041
        • Milton Haber, M.D.
      • Laredo, Texas, United States, 78041
        • Andres Garcia-Zuniga, MD, P.A
      • Longview, Texas, United States, 75605
        • DCOL Ctr for Clin Res
      • Plano, Texas, United States, 75075
        • Clinical Investigations Of Texas
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes &Endocrinology
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • San Antonio, Texas, United States, 78229
        • Audie L. Murphy VA Hospital
      • San Antonio, Texas, United States, 78224
        • Briggs Clinical Research, LLC
      • San Antonio, Texas, United States, 78229
        • Diabetes Glandular Diseases Clinic
      • San Antonio, Texas, United States, 78229
        • Diabetes & Gladular Disease Research A Cetero Research Co
      • San Marcos, Texas, United States, 78666
        • Javara Inc Privia Grp Gulf Cst
      • Sugar Land, Texas, United States, 77478
        • SimCare, PLLC
      • Sugar Land, Texas, United States, 77479
        • Sugar Lakes Family Practice PA
      • Waco, Texas, United States, 76708
        • Hillcrest Family Health Center
    • Virginia
      • Appomattox, Virginia, United States, 24522
        • Javara Inc. / Privia Medical Group LLC_Appomattox
      • Forest, Virginia, United States, 24551
        • Javara Inc/Privia Md GpLLC Fst
      • Norfolk, Virginia, United States, 23510
        • Eastern Virginia Medical School
      • Winchester, Virginia, United States, 22601
        • Amherst Family Practice P.C.
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Sound Medical Research
      • Renton, Washington, United States, 98057
        • Rainier Clin Res Ctr Inc
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Ascension Columbia St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key inclusion criteria

  1. Male or female and age above or equal to 18 years at the time of signing informed consent.
  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.

Key exclusion criteria

  1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  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).
  3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IcoSema
Drug: IcoSema
Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Active Comparator: Insulin icodec
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (Week 0), Week 52
Change from baseline (week 0) to week 52 in HbA1c is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
Baseline (Week 0), Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Baseline (Week 0), Week 52
Change from baseline (week 0) to week 52 in body weight is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
Baseline (Week 0), Week 52
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3)
Time Frame: From baseline week 0 to week 57
Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (<) 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
From baseline week 0 to week 57
Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6
Time Frame: From week 48 to week 52
Time in range was defined as 100 times the number of recorded measurements in glycemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
From week 48 to week 52
Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6
Time Frame: From week 48 to week 52
Time spent below threshold was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
From week 48 to week 52
Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6
Time Frame: From week 48 to week 52
Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
From week 48 to week 52
Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline (Week 0), Week 52
Change in FPG from baseline (week 0) to week 52 is presented. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
Baseline (Week 0), Week 52
Weekly Basal Insulin Dose
Time Frame: From week 50 to week 52
Estimated mean average weekly basal insulin dose from week 50 to week 52 of treatment is presented. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
From week 50 to week 52
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)
Time Frame: From baseline week 0 to week 57
Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (<) 3.0 mmol/L (54 mg/dL). The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
From baseline week 0 to week 57
Number of Severe Hypoglycaemic Episodes (Level 3)
Time Frame: From baseline week 0 to week 57
Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
From baseline week 0 to week 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

March 19, 2024

Study Completion (Actual)

April 23, 2024

Study Registration Dates

First Submitted

April 24, 2022

First Submitted That Met QC Criteria

April 24, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1535-4591
  • U1111-1260-8259 (Other Identifier: World Health Organization (WHO))
  • 2020-005281-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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