AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3COMBINE 1NCT05352815

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

A Phase 3 study testing IcoSema and Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 281 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
IcoSema and Insulin icodec
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,291 participants
Where
281 sitesin 22 countries
Study dates
1 Jun 2022to 23 Apr 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female and age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
  • HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
  • 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)
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  • 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.
  • 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.

Who cannot join

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  • 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).
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
  • Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening.
  • Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
  • Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
Show all 9Show fewer
  • Chronic heart failure classified as being in New York Heart Association Class IV at screening.
  • Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
  • 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.

Trial locations and contacts

281 sites in 22 countries.

281 sites in 22 countries

United States110 sites

  • Javara/Privia Med Grp GA,LLC

    Albany, Georgia, 31707

  • Albuquerque Clin Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106

  • Javara Inc. / Privia Medical Group LLC_Appomattox

    Appomattox, Virginia, 24522

  • Athens Medical Group

    Athens, Tennessee, 37303

  • Emory University SOM

    Atlanta, Georgia, 30303

  • Texas Diabetes & Endocrinology, P.A._Austin

    Austin, Texas, 78731

  • Texas Diabetes & Endocrinology, P.A._Austin

    Austin, Texas, 78749

  • AM Diabetes And Endocrinology Center

    Bartlett, Tennessee, 38133

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115-5804

  • Holston Medical Group_Bristol

    Bristol, Tennessee, 37620

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • Javara Inc. / Tryon Medical Partners PLLC

    Charlotte, North Carolina, 28287

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • Univ Diab & Endo Consultants

    Chattanooga, Tennessee, 37411

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Clinical Res Of W Florida Inc

    Clearwater, Florida, 33765

  • Central Ohio Clinical Research LLC

    Columbus, Ohio, 43213

  • John Muir Physicians Network

    Concord, California, 94520

  • Osvaldo A. Brusco MD PA

    Corpus Christi, Texas, 78414

  • Cedar Research

    Dallas, Texas, 75038

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Univ of TX SW Med Ctr Dallas

    Dallas, Texas, 75390-9302

  • Creekside Endocrine Associates, PC

    Denver, Colorado, 80246

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Javara Inc.

    Fayetteville, Georgia, 30214

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Elite Research Center

    Flint, Michigan, 48532

  • Javara Inc/Privia Md GpLLC Fst

    Forest, Virginia, 24551

  • Diabetes and Thyroid Ctr of FW

    Fort Worth, Texas, 76132

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Pri Med Grp dba/Gil Ctr Fam

    Gilbert, Arizona, 85296

  • Lenzmeier Fam Med CCT Research

    Glendale, Arizona, 85308

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • Javara Inc. / Privia Medical Group Gulf Coast PLLC

    Houston, Texas, 77054

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • MedStar Hlth Res Institute

    Hyattsville, Maryland, 20782

  • Jefferson City Medical Group, PC

    Jefferson City, Missouri, 65109

  • Medical Colleagues-Texas LLP

    Katy, Texas, 77450

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • Andres Garcia-Zuniga, MD, P.A

    Laredo, Texas, 78041

  • Milton Haber, M.D.

    Laredo, Texas, 78041

  • University of Nevada School of Medicine

    Las Vegas, Nevada, 89102

  • Palm Research Center Inc.

    Las Vegas, Nevada, 89148

  • Physicians Research Assoc. LLC

    Lawrenceville, Georgia, 30046

  • John J Shelmet, MD

    Lawrenceville, New Jersey, 08648

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503

  • Clinical Trials Research_Sacramento

    Lincoln, California, 95648

  • Medical Investigations, Inc.

    Little Rock, Arkansas, 72211

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • Pacific Clinical Studies

    Los Alamitos, California, 90720

  • Downtown LA Res Ctr. Inc.

    Los Angeles, California, 90017

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • University of Miami

    Miami, Florida, 33136

  • Ascension Columbia St. Mary's Hospital

    Milwaukee, Wisconsin, 53211

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • HealthStar Physicians PC

    Morristown, Tennessee, 37813

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, Florida, 32757

  • Saltzer Medical Group Research

    Nampa, Idaho, 83686-6011

  • Southern New Hampshire Diabete

    Nashua, New Hampshire, 03060

  • Barnum Medical Research Inc.

    Natchitoches, Louisiana, 71457

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Suncoast Clin Res Port Richey

    New Port Richey, Florida, 34652

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York, 12553

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510

  • Intend Research

    Norman, Oklahoma, 73069

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York, 11758-1802

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Methodist Phys. Clinic

    Omaha, Nebraska, 68114

  • University of NE Med Ctr

    Omaha, Nebraska, 68198

  • Clinical Neuroscience Solution

    Orlando, Florida, 32801

  • Florida Inst For Clin Res

    Orlando, Florida, 32825

  • UnityPoint Health-Diabetes Care Center

    Peoria, Illinois, 61603

  • Phoenician Centers for Research & Innovation PCRI

    Phoenix, Arizona, 85021

  • Clinical Investigations Of Texas

    Plano, Texas, 75075

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • Texas Diabetes &Endocrinology

    Round Rock, Texas, 78681

  • Clinical Trials Research_Sacramento_0

    Sacramento, California, 95821

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Briggs Clinical Research, LLC

    San Antonio, Texas, 78224

  • Audie L. Murphy VA Hospital

    San Antonio, Texas, 78229

  • Diabetes & Gladular Disease Research A Cetero Research Co

    San Antonio, Texas, 78229

  • Diabetes Glandular Diseases Clinic

    San Antonio, Texas, 78229

  • San Diego Family Care

    San Diego, California, 92111

  • Javara Inc Privia Grp Gulf Cst

    San Marcos, Texas, 78666

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • Endeavor Health

    Skokie, Illinois, 60077

  • Ileana J Tandron APMC

    Slidell, Louisiana, 70461-4231

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

  • SimCare, PLLC

    Sugar Land, Texas, 77478

  • Sugar Lakes Family Practice PA

    Sugar Land, Texas, 77479

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Cotton O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • Hillcrest Family Health Center

    Waco, Texas, 76708

  • New Venture Medical Research

    Wadsworth, Ohio, 44281

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • MassResearch, LLC

    Waltham, Massachusetts, 02453

  • Care Access

    Warwick, Rhode Island, 02886

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Amherst Family Practice P.C.

    Winchester, Virginia, 22601

Other trials in United States

India23 sites

  • Gujarat Endocrine Centre

    Ahmedabad, Gujarat, 380052

  • Lifecare Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • Post Graduate Institute of Medical Education & Research

    Chandigarh, Punjab, 160012

  • M.V.Hospital for Diabetes Pvt. Ltd.

    Chennai, Tamil Nadu, 600 013

  • S.C.B. Medical College

    Cuttack, Odisha, 753007

  • Apollo Excelcare Hospital

    Guwahati, Assam, 781033

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Ramdev Rao Hospital

    Hyderabad, Telangana, 500072

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh, 452010

  • Excel Endocrine Centre

    Kolhāpur, Maharashtra, 416008

  • Government Medical College, Kozhikode

    Kozhikode, Kerala, 673008

  • Dayanand Medical College & Hospital_Ludhiana

    Ludhiana, Punjab, 141001

  • Arthur Asirvatham hospital,

    Madurai, Tamil Nadu, 625020

  • BYL Nair Hospital and T N Medical College Department of endo

    Mumbai, Maharashtra, 400008

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Bhaktivedanta Hospital & Research Institute

    Mumbai, Maharashtra, 401107

  • Mysore Medical College and Research Institute

    Mysore, Karnataka, 570001

  • Lady Hardinge Medical College

    New Delhi, 110001

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Inamdar Multispeciality Hospital

    Pune, Maharashtra, 411040

  • Yashoda Hospital

    Secunderabad, Andhra Pradesh, 500003

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

  • Jothydev's Diabetes & Research Center

    Thriruvananthapuram, Kerala, 695 032

Other trials in India

Japan18 sites

  • Kumanomae Nishimura Naika Clinic_Internal Medicine

    Arakawa-ku, Tokyo, 116-0012

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804

  • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

    Chigasaki-shi, Kanagawa, Japan, 253-0044

  • Hayashi Diabetes Clinic

    Chigasaki-shi, Kanagawa, Kanagawa, Japan, 253-0044

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006

  • Futata Tetsuhiro Clinic Meinohama

    Fukuoka-shi, Fukuoka, 819-0006

  • Kunisaki Makoto Clinic

    Fukuoka-shi, Fukuoka, 819-0168

  • Sasaki Internal Medicine

    Hokkaido, 062-0007

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Japan, 963-8851

  • Jinnouchi Hospital_Internal Medicine

    Kumamoto, Kumamoto, Japan, 862-0976

  • Yoshimura clinic

    Kumamoto, 861-8039

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034

  • Heiwadai Hospital

    Miyazaki, Miyazaki, 880-0034

  • Hisatomi Clinic

    Saga-shi, Saga, 840-0937

  • Manda Memorial Hospital_Internal Medicine

    Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Yokohama City University Hospital, Endocrinology, Metabolism

    Yokohama-shi, Kanagawa, 236-0004

Other trials in Japan

China17 sites

  • Peking University People's Hospital-Endocrinology

    Beijing, Beijing Municipality, 100044

  • Changzhou No.2 People's Hospital, Yanghu Branch

    Changzhou, Jiangsu, 213003

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213004

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • Anhui Provincial Hospital-Endocrinology

    Hefei, Anhui, 230001

  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

  • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

    Hengshui, Hebei, 053000

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong, 516001

  • Jinan Central Hospital Affiliated to Shandong University

    Jinan, Shandong, 250013

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan, 475000

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011

  • The Second Affiliated Hospital of Nanjing Medical University_Nanjing

    Nanjing, Jiangsu, 210011

  • Shanghai Fifth People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 200240

  • The Second Affiliated Hospital of Soochow University-Endocrinology

    Suzhou, Jiangsu, 215004

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin, Tianjin Municipality, 300052

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001

Other trials in China

South Korea13 sites

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, 15355

  • The Catholic University of Korea, Bucheon ST. Mary's Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Soonchunhyang University Hospital

    Cheonan, Chungcheongnam-do, 31151

  • Seoul National University Bundang Hospital_Seongnam-si

    Seongnam-si, 463-707

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Seoul Saint Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 139-827

  • Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Portugal12 sites

  • Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta

    Almada, 2805-267

  • Unidade Local De Saude De Amadora Sintra E.P.E. - Hospital Prof. Dr. Fernando da Fonseca

    Amadora, 2720-276

  • Unidade Local De Saude Da Regiao De Aveiro E.P.E.

    Aveiro, 3814-501

  • Unidade de Local de Saúde de Braga

    Braga, 4710-243

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-189

  • Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz

    Lisbon, 1349-019

  • Hospital Da Luz S.A.

    Lisbon, 1500-650

  • Unidade Local de Saúde de Matosinhos

    Matosinhos Municipality, 4464-513

  • Unidade Local de Saúde de Santo António, E.P.E

    Porto, 4099-001

  • Unidade Local De Saude De Matosinhos E.P.E.

    Senhora Da Hora, Matosinhos, Matosinhos, 4464-513

  • Hospital Luz Arrabida, S.A.

    Vila Nova de Gaia, 4400-346

  • Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.

    Vila Real, 5000-508

Other trials in Portugal

Australia10 sites

  • Holdsworth House Clinical Research

    Darlinghurst, New South Wales, 2010

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales, 2010

  • The Canberra Hospital_Garran

    Garran, Australian Capital Territory, 2605

  • Barwon Health (The Geelong Hospital)

    Geelong, Victoria, 3220

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Novatrials

    Kotara, New South Wales, 2289

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia, 5046

  • Illawarra Diabetes Service Clinical Trials & Research Unit

    Wollongong, New South Wales, 2500

Other trials in Australia

Belgium7 sites

  • Imeldaziekenhuis - Bonheiden - Department of Endocrinology

    Bonheiden, 2820

  • UZ Brussel - Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Brussels, 1200

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650

  • AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie

    Kortrijk, 8500

  • CHU Tivoli

    La Louvière, 7100

  • UZ Leuven - Endocrinology

    Leuven, 3000

Other trials in Belgium

Norway7 sites

  • Nordlandssykehuset Bodø

    Bodø, 8005

  • Drammen sykehus - Vestre Viken HF

    Drammen, 3004

  • Bærum sykehus

    Gjettum, 1346

  • Sykehuset Innlandet HF Hamar

    Hamar, 2318

  • Akershus universitetssykehus HF

    Lørenskog, 1478

  • Oslo universitetssykehus Aker

    Oslo, 0586

  • St. Olavs Hospital HF

    Trondheim, NO-7030

Other trials in Norway

Russia7 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • Irkutsk State Medical Academy of Postgraduate Education

    Irkutsk, 664049

  • Limited Liability Company "AriVa-Med"

    Kursk, 305016

  • City Consultative & Diagnostic Centre #1

    Saint Petersburg, 194354

  • Saratov regional clinical hospital

    Saratov, 410053

  • Tumen State Medical University

    Tyumen, Russia, 625023

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

South Africa7 sites

  • Netcare Alberton Hospital

    Alberton, 1449

  • Armansis Medical Centre

    Brits, North West, 0250

  • Langeberg Clinical Trials

    Cape Town, Western Cape, 7572

  • Dr Pillay's Rooms

    Durban, KwaZulu-Natal, 4450

  • Deepak Lakha

    Johannesburg, Gauteng, 1820

  • Hemant Makan

    Johannesburg, Gauteng, 1827

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng, 2013

Other trials in South Africa

Turkey (Türkiye)7 sites

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji

    Adana, 01150

  • Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi-Endokrinoloji

    Ankara, Altindag, 06230

  • Gulhane Egitim Arastirma Hastanesi

    Ankara, 06010

  • Haseki Eğitim ve Araştırma Hastanesi- Dahiliye

    Istanbul, 34098

  • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

    Istanbul, 34722

  • T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34899

  • Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye

    Tekirdağ, 59030

Other trials in Turkey (Türkiye)

Finland6 sites

  • Ähtärin terveysasema

    Ähtäri, 63700

  • Health Step Finland Oy

    Kuopio, 70210

  • Etelä-Savon sosiaali- ja terveyspalvelujen kuntayhtymä

    Mikkeli, 50100

  • Raision sosiaali- ja terveyskeskus

    Raisio, 21200

  • Tampereen diabetesvastaanotto

    Tampere, 33900

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Italy6 sites

  • A.O.U. Consorziale Policlinico di Bari

    Bari, BA, 70124

  • Policlinico Mater Domini Università di Catanzaro

    Catanzaro, 88100

  • ASL 4 Chiavarese

    Chiavari (genova), 16043

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Pol. Uni. Campus Biomedico

    Roma, RM, 00128

Other trials in Italy

Romania6 sites

  • CMI Diabet, Nutritie, Boli Metabolice "Dr Pop Lavinia"

    Baia Mare, Maramureş, 430222

  • Mariodiab Clinic SRL

    Brasov, 500101

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucurestii, 020475

  • SC Consultmed SRL

    Iași, 700547

  • Clinica Korall S.R.L. Satu Mare

    Satu Mare, 440055

  • Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava

    Suceava, 720237

Other trials in Romania

Bulgaria5 sites

  • IPSMC - Dr. Nikolay Kostadinov EOOD

    Burgas, 8000

  • Medical center Medi City 21 OOD

    Kyustendil, 2500

  • DCC I- Pleven EOOD Endocrinology

    Pleven, 5801

  • UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic

    Plovdiv, 4001

  • MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases

    Sofia, 1606

Other trials in Bulgaria

Croatia5 sites

  • Poliklinika SLAVONIJA OSIJEK

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki bolnicki centar Osijek

    Osijek, 31 000

  • Opca bolnica Pula

    Pula, 52100

  • KBC Rijeka, Endokrinologija

    Rijeka, 51000

  • Poliklinika Solmed

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Taiwan5 sites

  • Changhua Christian Hospital_Metabolic Dept.

    Changhua, 500

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Medical Center

    Tainan, 710

  • Taipei Medical University Hospital

    Taipei, 110

Other trials in Taiwan

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, 80-214

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelski, 20-538

  • NZOZ "CenterMed Lublin" Sp. z o.o.

    Lublin, 20-044

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507

Other trials in Poland

Mexico3 sites

  • Centro de Investigación Cardiometabólica de Aguascalientes

    Aguascalientes, 20230

  • Clínicos Asociados BOCM, S.C.

    Mexico City, 03300

  • Hospital Universitario Dr. José Eleuterio González_Monterrey

    Monterrey, Nuevo León, 64460

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Puerto Rico2 sites

  • Advanced Clinical Research LLC

    Bayamón, 00959

  • Manati Ctr For Clin Research

    Manati, 00674

Other trials in Puerto Rico

Serbia1 site

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: 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.

Read more

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.

Being tested
IcoSema, Insulin icodec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IcoSemaDrug

    Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.

  • Insulin icodecDrug

    Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.

Study groups in NCT05352815
Study groupRoleWhat they receive
IcoSemaExperimentalNot described
Receives: Drug: IcoSema
Insulin icodecActive comparatorNot described
Receives: Drug: Insulin icodec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated Haemoglobin (HbA1c)

    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.

    Measured: Baseline (Week 0), Week 52

Secondary outcomes (9)

  1. Change in Body Weight

    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.

    Measured: Baseline (Week 0), Week 52

  2. 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)

    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.

    Measured: From baseline week 0 to week 57

  3. Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6

    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.

    Measured: From week 48 to week 52

  4. Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6

    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.

    Measured: From week 48 to week 52

  5. Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6

    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.

    Measured: From week 48 to week 52

  6. Change in Fasting Plasma Glucose (FPG)

    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.

    Measured: Baseline (Week 0), Week 52

  7. Weekly Basal Insulin Dose

    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.

    Measured: From week 50 to week 52

  8. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)

    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.

    Measured: From baseline week 0 to week 57

  9. Number of Severe Hypoglycaemic Episodes (Level 3)

    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.

    Measured: From baseline week 0 to week 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start1 Jun 2022
  3. Primary completion19 Mar 2024
  4. Study completion23 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352815
Sponsor's protocol ID
NN1535-4591
Other IDs
U1111-1260-8259, 2020-005281-34
Acronym
COMBINE 1
Status last verified
Nov 2025
First submitted
24 Apr 2022
Last updated
4 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Ji L, Andersen JD, Benamar M, Ponzani P, Unnikrishnan AG, Vinther S, Rea R. Efficacy and Hypoglycaemia Outcomes With Once-Weekly IcoSema Versus Comparators in Individuals With Type 2 Diabetes by Kidney and Liver Function: A Post Hoc Analysis of the COMBINE 1-3 Trials. Diabetes Obes Metab. 2026 Aug 5. doi: 10.1111/dom.70895. Online ahead of print.

    PubMed 42557064

  • De Block C, Benamar M, Fu A, Maltesen R, Giorgino F. CGM-derived postprandial glucose with IcoSema versus other insulin regimens: a post hoc analysis of COMBINE 1 and 3. EClinicalMedicine. 2026 Jun 4;96:103985. doi: 10.1016/j.eclinm.2026.103985. eCollection 2026 Jun.

    PubMed 42306490

  • 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.

    PubMed 40482671

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IcoSema and Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 281 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 281 sites in United States, India, Japan, China, South Korea and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (Week 0), Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352815, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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