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

NCT05352815 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: NN1535-4591U1111-1260-82592020-005281-34
• Study Type: interventional
• Target: 1,291
• Locations: 22 countries
• Sites: 281

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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.

  Baseline (Week 0), Week 52

Secondary Outcomes (9)

• Change in Body Weight

  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)

  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

  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

  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

  From week 48 to week 52

Study Arms (2)

IcoSema

EXPERIMENTAL

Drug: IcoSema

Insulin icodec

ACTIVE COMPARATOR

Drug: Insulin icodec

Interventions

IcoSema DRUG

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

IcoSema

Insulin icodec DRUG

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

Insulin icodec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (281)

Pri Med Grp dba/Gil Ctr Fam

Gilbert, Arizona, 85296, United States

Location

Lenzmeier Fam Med CCT Research

Glendale, Arizona, 85308, United States

Location

Phoenician Centers for Research & Innovation PCRI

Phoenix, Arizona, 85021, United States

Location

Medical Investigations, Inc.

Little Rock, Arkansas, 72211, United States

Location

John Muir Physicians Network

Concord, California, 94520, United States

Location

Headlands Research California, LLC

Escondido, California, 92025, United States

Location

Scripps Whittier Diabetes Inst

La Jolla, California, 92037, United States

Location

Clinical Trials Research_Sacramento

Lincoln, California, 95648, United States

Location

Torrance Clin Res Inst, Inc.

Lomita, California, 90717, United States

Location

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

Location

Downtown LA Res Ctr. Inc.

Los Angeles, California, 90017, United States

Location

Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Clinical Trials Research_Sacramento_0

Sacramento, California, 95821, United States

Location

San Diego Family Care

San Diego, California, 92111, United States

Location

NorCal Endocrinology and Internal Medicine

San Ramon, California, 94583, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Creekside Endocrine Associates, PC

Denver, Colorado, 80246, United States

Location

Clinical Res Of W Florida Inc

Clearwater, Florida, 33765, United States

Location

Northeast Research Institute

Fleming Island, Florida, 32003, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida, 32757, United States

Location

Suncoast Clin Res Port Richey

New Port Richey, Florida, 34652, United States

Location

Clinical Neuroscience Solution

Orlando, Florida, 32801, United States

Location

Florida Inst For Clin Res

Orlando, Florida, 32825, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

Javara/Privia Med Grp GA,LLC

Albany, Georgia, 31707, United States

Location

Emory University SOM

Atlanta, Georgia, 30303, United States

Location

Javara Inc.

Fayetteville, Georgia, 30214, United States

Location

Physicians Research Assoc. LLC

Lawrenceville, Georgia, 30046, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

Location

Saltzer Medical Group Research

Nampa, Idaho, 83686-6011, United States

Location

UnityPoint Health-Diabetes Care Center

Peoria, Illinois, 61603, United States

Location

Endeavor Health

Skokie, Illinois, 60077, United States

Location

Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States

Location

Cotton O'Neil Diab & Endo Ctr

Topeka, Kansas, 66606, United States

Location

The Research Group of Lexington LLC

Lexington, Kentucky, 40503, United States

Location

Barnum Medical Research Inc.

Natchitoches, Louisiana, 71457, United States

Location

New Orleans Center for Clinical Research

New Orleans, Louisiana, 70119, United States

Location

Ileana J Tandron APMC

Slidell, Louisiana, 70461-4231, United States

Location

MedStar Hlth Res Institute

Hyattsville, Maryland, 20782, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115-5804, United States

Location

MassResearch, LLC

Waltham, Massachusetts, 02453, United States

Location

Northern Pines Hlth Ctr, PC

Buckley, Michigan, 49620, United States

Location

Elite Research Center

Flint, Michigan, 48532, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

Jefferson City Medical Group, PC

Jefferson City, Missouri, 65109, United States

Location

Methodist Phys. Clinic

Omaha, Nebraska, 68114, United States

Location

University of NE Med Ctr

Omaha, Nebraska, 68198, United States

Location

University of Nevada School of Medicine

Las Vegas, Nevada, 89102, United States

Location

Palm Research Center Inc.

Las Vegas, Nevada, 89148, United States

Location

Southern New Hampshire Diabete

Nashua, New Hampshire, 03060, United States

Location

John J Shelmet, MD

Lawrenceville, New Jersey, 08648, United States

Location

Albuquerque Clin Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Mid Hudson Medical Research, PLLC

New Windsor, New York, 12553, United States

Location

DiGiovanna Institute for Medical Education & Research

North Massapequa, New York, 11758-1802, United States

Location

Endocrine Associates of Long Island, PC

Smithtown, New York, 11787, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

Location

Javara Inc. / Tryon Medical Partners PLLC

Charlotte, North Carolina, 28287, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Central Ohio Clinical Research LLC

Columbus, Ohio, 43213, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

New Venture Medical Research

Wadsworth, Ohio, 44281, United States

Location

Intend Research

Norman, Oklahoma, 73069, United States

Location

Care Access

Warwick, Rhode Island, 02886, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Athens Medical Group

Athens, Tennessee, 37303, United States

Location

AM Diabetes And Endocrinology Center

Bartlett, Tennessee, 38133, United States

Location

Holston Medical Group_Bristol

Bristol, Tennessee, 37620, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Univ Diab & Endo Consultants

Chattanooga, Tennessee, 37411, United States

Location

HealthStar Physicians PC

Morristown, Tennessee, 37813, United States

Location

Amarillo Med Spec LLP

Amarillo, Texas, 79106, United States

Location

Texas Diabetes & Endocrinology, P.A._Austin

Austin, Texas, 78731, United States

Location

Texas Diabetes & Endocrinology, P.A._Austin

Austin, Texas, 78749, United States

Location

Osvaldo A. Brusco MD PA

Corpus Christi, Texas, 78414, United States

Location

Cedar Research

Dallas, Texas, 75038, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

North Texas Endocrine Center

Dallas, Texas, 75231, United States

Location

Univ of TX SW Med Ctr Dallas

Dallas, Texas, 75390-9302, United States

Location

Diabetes and Thyroid Ctr of FW

Fort Worth, Texas, 76132, United States

Location

PrimeCare Medical Group

Houston, Texas, 77024, United States

Location

Javara Inc. / Privia Medical Group Gulf Coast PLLC

Houston, Texas, 77054, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Protenium Clinical Research

Hurst, Texas, 76054, United States

Location

Medical Colleagues-Texas LLP

Katy, Texas, 77450, United States

Location

Andres Garcia-Zuniga, MD, P.A

Laredo, Texas, 78041, United States

Location

Milton Haber, M.D.

Laredo, Texas, 78041, United States

Location

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

Location

Clinical Investigations Of Texas

Plano, Texas, 75075, United States

Location

Texas Diabetes &Endocrinology

Round Rock, Texas, 78681, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Briggs Clinical Research, LLC

San Antonio, Texas, 78224, United States

Location

Audie L. Murphy VA Hospital

San Antonio, Texas, 78229, United States

Location

Diabetes & Gladular Disease Research A Cetero Research Co

San Antonio, Texas, 78229, United States

Location

Diabetes Glandular Diseases Clinic

San Antonio, Texas, 78229, United States

Location

Javara Inc Privia Grp Gulf Cst

San Marcos, Texas, 78666, United States

Location

SimCare, PLLC

Sugar Land, Texas, 77478, United States

Location

Sugar Lakes Family Practice PA

Sugar Land, Texas, 77479, United States

Location

Hillcrest Family Health Center

Waco, Texas, 76708, United States

Location

Javara Inc. / Privia Medical Group LLC_Appomattox

Appomattox, Virginia, 24522, United States

Location

Javara Inc/Privia Md GpLLC Fst

Forest, Virginia, 24551, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Amherst Family Practice P.C.

Winchester, Virginia, 22601, United States

Location

Sound Medical Research

Port Orchard, Washington, 98366, United States

Location

Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States

Location

Ascension Columbia St. Mary's Hospital

Milwaukee, Wisconsin, 53211, United States

Location

The Canberra Hospital_Garran

Garran, Australian Capital Territory, 2605, Australia

Location

Holdsworth House Clinical Research

Darlinghurst, New South Wales, 2010, Australia

Location

Momentum Clinical Research Darlinghurst

Darlinghurst, New South Wales, 2010, Australia

Location

Novatrials

Kotara, New South Wales, 2289, Australia

Location

Illawarra Diabetes Service Clinical Trials & Research Unit

Wollongong, New South Wales, 2500, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, South Australia, 5046, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Barwon Health (The Geelong Hospital)

Geelong, Victoria, 3220, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Imeldaziekenhuis - Bonheiden - Department of Endocrinology

Bonheiden, 2820, Belgium

Location

UZ Brussel - Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

Brussels, 1200, Belgium

Location

UZA - UZ Antwerpen - Department of Endocrinology

Edegem, 2650, Belgium

Location

AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie

Kortrijk, 8500, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

UZ Leuven - Endocrinology

Leuven, 3000, Belgium

Location

IPSMC - Dr. Nikolay Kostadinov EOOD

Burgas, 8000, Bulgaria

Location

Medical center Medi City 21 OOD

Kyustendil, 2500, Bulgaria

Location

DCC I- Pleven EOOD Endocrinology

Pleven, 5801, Bulgaria

Location

UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic

Plovdiv, 4001, Bulgaria

Location

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

Sofia, 1606, Bulgaria

Location

Anhui Provincial Hospital-Endocrinology

Hefei, Anhui, 230001, China

Location

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, 100044, China

Location

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

Huizhou Central People's Hospital-Endocrinology

Huizhou, Guangdong, 516001, China

Location

Harrison International Peace Hospital

Hengshui, Hebei, 053000, China

Location

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

Hengshui, Hebei, 053000, China

Location

Huaihe Hospital of Henan University-Endocrinology

Kaifeng, Henan, 475000, China

Location

Changzhou No.2 People's Hospital, Yanghu Branch

Changzhou, Jiangsu, 213003, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213004, China

Location

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

Location

The Second Affiliated Hospital of Nanjing Medical University_Nanjing

Nanjing, Jiangsu, 210011, China

Location

The Second Affiliated Hospital of Soochow University-Endocrinology

Suzhou, Jiangsu, 215004, China

Location

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China

Location

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, 250013, China

Location

Shanghai Fifth People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, 200240, China

Location

General Hospital of Tianjin Medical University-Endocrinology

Tianjin, Tianjin Municipality, 300052, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

Poliklinika Solmed

Zagreb, City of Zagreb, 10000, Croatia

Location

Poliklinika SLAVONIJA OSIJEK

Osijek, County of Osijek-Baranja, 31000, Croatia

Location

Klinicki bolnicki centar Osijek

Osijek, 31 000, Croatia

Location

Opca bolnica Pula

Pula, 52100, Croatia

Location

KBC Rijeka, Endokrinologija

Rijeka, 51000, Croatia

Location

Ähtärin terveysasema

Ähtäri, 63700, Finland

Location

Health Step Finland Oy

Kuopio, 70210, Finland

Location

Etelä-Savon sosiaali- ja terveyspalvelujen kuntayhtymä

Mikkeli, 50100, Finland

Location

Raision sosiaali- ja terveyskeskus

Raisio, 21200, Finland

Location

Tampereen diabetesvastaanotto

Tampere, 33900, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

Yashoda Hospital

Secunderabad, Andhra Pradesh, 500003, India

Location

Apollo Excelcare Hospital

Guwahati, Assam, 781033, India

Location

Gujarat Endocrine Centre

Ahmedabad, Gujarat, 380052, India

Location

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, 395002, India

Location

Lifecare Hospital and Research Centre

Bangalore, Karnataka, 560092, India

Location

Mysore Medical College and Research Institute

Mysore, Karnataka, 570001, India

Location

Government Medical College, Kozhikode

Kozhikode, Kerala, 673008, India

Location

Jothydev's Diabetes & Research Center

Thriruvananthapuram, Kerala, 695 032, India

Location

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, 452010, India

Location

Excel Endocrine Centre

Kolhāpur, Maharashtra, 416008, India

Location

BYL Nair Hospital and T N Medical College Department of endo

Mumbai, Maharashtra, 400008, India

Location

Seth GS medical college and KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Bhaktivedanta Hospital & Research Institute

Mumbai, Maharashtra, 401107, India

Location

Inamdar Multispeciality Hospital

Pune, Maharashtra, 411040, India

Location

S.C.B. Medical College

Cuttack, Odisha, 753007, India

Location

Post Graduate Institute of Medical Education & Research

Chandigarh, Punjab, 160012, India

Location

Dayanand Medical College & Hospital_Ludhiana

Ludhiana, Punjab, 141001, India

Location

M.V.Hospital for Diabetes Pvt. Ltd.

Chennai, Tamil Nadu, 600 013, India

Location

Arthur Asirvatham hospital,

Madurai, Tamil Nadu, 625020, India

Location

Osmania General Hospital

Hyderabad, Telangana, 500012, India

Location

Ramdev Rao Hospital

Hyderabad, Telangana, 500072, India

Location

Lady Hardinge Medical College

New Delhi, 110001, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

A.O.U. Consorziale Policlinico di Bari

Bari, BA, 70124, Italy

Location

Pol. Uni. Campus Biomedico

Roma, RM, 00128, Italy

Location

Policlinico Mater Domini Università di Catanzaro

Catanzaro, 88100, Italy

Location

ASL 4 Chiavarese

Chiavari (genova), 16043, Italy

Location

Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Japan, 963-8851, Japan

Location

Manda Memorial Hospital_Internal Medicine

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

Location

Hayashi Diabetes Clinic

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

Location

Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

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

Location

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, 862-0976, Japan

Location

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, 880-0034, Japan

Location

Heiwadai Hospital

Miyazaki, Miyazaki, 880-0034, Japan

Location

Kumanomae Nishimura Naika Clinic_Internal Medicine

Arakawa-ku, Tokyo, 116-0012, Japan

Location

Akaicho Clinic

Chiba-shi, Chiba, 260-0804, Japan

Location

Futata Tetsuhiro Clinic Meinohama_Internal medicine

Fukuoka-shi, Fukuoka, 819-0006, Japan

Location

Futata Tetsuhiro Clinic Meinohama

Fukuoka-shi, Fukuoka, 819-0006, Japan

Location

Kunisaki Makoto Clinic

Fukuoka-shi, Fukuoka, 819-0168, Japan

Location

Sasaki Internal Medicine

Hokkaido, 062-0007, Japan

Location

Yoshimura clinic

Kumamoto, 861-8039, Japan

Location

Hisatomi Clinic

Saga-shi, Saga, 840-0937, Japan

Location

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

Location

Fukuwa Clinic_Internal Medicine

Tokyo, 104-0031, Japan

Location

Yokohama City University Hospital, Endocrinology, Metabolism

Yokohama-shi, Kanagawa, 236-0004, Japan

Location

Hospital Universitario Dr. José Eleuterio González_Monterrey

Monterrey, Nuevo León, 64460, Mexico

Location

Centro de Investigación Cardiometabólica de Aguascalientes

Aguascalientes, 20230, Mexico

Location

Clínicos Asociados BOCM, S.C.

Mexico City, 03300, Mexico

Location

Nordlandssykehuset Bodø

Bodø, 8005, Norway

Location

Drammen sykehus - Vestre Viken HF

Drammen, 3004, Norway

Location

Bærum sykehus

Gjettum, 1346, Norway

Location

Sykehuset Innlandet HF Hamar

Hamar, 2318, Norway

Location

Akershus universitetssykehus HF

Lørenskog, 1478, Norway

Location

Oslo universitetssykehus Aker

Oslo, 0586, Norway

Location

St. Olavs Hospital HF

Trondheim, NO-7030, Norway

Location

NZOZ Przychodnia Specjalistyczna Medica

Lublin, Lubelski, 20-538, Poland

Location

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, 80-214, Poland

Location

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

Lublin, 20-044, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, 02-507, Poland

Location

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

Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal

Location

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

Almada, 2805-267, Portugal

Location

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

Amadora, 2720-276, Portugal

Location

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

Aveiro, 3814-501, Portugal

Location

Unidade de Local de Saúde de Braga

Braga, 4710-243, Portugal

Location

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, 1250-189, Portugal

Location

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

Lisbon, 1349-019, Portugal

Location

Hospital Da Luz S.A.

Lisbon, 1500-650, Portugal

Location

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, 4464-513, Portugal

Location

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

Porto, 4099-001, Portugal

Location

Hospital Luz Arrabida, S.A.

Vila Nova de Gaia, 4400-346, Portugal

Location

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

Vila Real, 5000-508, Portugal

Location

Advanced Clinical Research LLC

Bayamón, 00959, Puerto Rico

Location

Manati Ctr For Clin Research

Manatí, 00674, Puerto Rico

Location

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

Bucharest, Bucurestii, 020475, Romania

Location

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

Baia Mare, Maramureş, 430222, Romania

Location

Mariodiab Clinic SRL

Brasov, 500101, Romania

Location

SC Consultmed SRL

Iași, 700547, Romania

Location

Clinica Korall S.R.L. Satu Mare

Satu Mare, 440055, Romania

Location

Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava

Suceava, 720237, Romania

Location

Tumen State Medical University

Tyumen, Russia, 625023, Russia

Location

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, 163045, Russia

Location

Irkutsk State Medical Academy of Postgraduate Education

Irkutsk, 664049, Russia

Location

Limited Liability Company "AriVa-Med"

Kursk, 305016, Russia

Location

City Consultative & Diagnostic Centre #1

Saint Petersburg, 194354, Russia

Location

Saratov regional clinical hospital

Saratov, 410053, Russia

Location

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, 620102, Russia

Location

Endocrinology, Diabetes and Metabolism Diseases Clinic

Belgrade, 11000, Serbia

Location

Deepak Lakha

Johannesburg, Gauteng, 1820, South Africa

Location

Hemant Makan

Johannesburg, Gauteng, 1827, South Africa

Location

Wits Bara Clinical Trial Site

Johannesburg, Gauteng, 2013, South Africa

Location

Dr Pillay's Rooms

Durban, KwaZulu-Natal, 4450, South Africa

Location

Armansis Medical Centre

Brits, North West, 0250, South Africa

Location

Langeberg Clinical Trials

Cape Town, Western Cape, 7572, South Africa

Location

Netcare Alberton Hospital

Alberton, 1449, South Africa

Location

Soonchunhyang University Hospital

Cheonan, Chungcheongnam-do, 31151, South Korea

Location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 15355, South Korea

Location

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

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

Seoul National University Bundang Hospital_Seongnam-si

Seongnam-si, 463-707, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Seoul Saint Mary's Hospital

Seoul, 06591, South Korea

Location

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

Seoul, 06591, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 139-827, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Changhua Christian Hospital_Metabolic Dept.

Changhua, 500, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Chi Mei Medical Center

Tainan, 710, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi-Endokrinoloji

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji

Adana, 01150, Turkey (Türkiye)

Location

Gulhane Egitim Arastirma Hastanesi

Ankara, 06010, Turkey (Türkiye)

Location

Haseki Eğitim ve Araştırma Hastanesi- Dahiliye

Istanbul, 34098, Turkey (Türkiye)

Location

Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

Istanbul, 34722, Turkey (Türkiye)

Location

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

Istanbul, 34899, Turkey (Türkiye)

Location

Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye

Tekirdağ, 59030, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40482671 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 29, 2022
• Study Start: June 1, 2022
• Primary Completion: March 19, 2024
• Study Completion: April 23, 2024
• Last Updated: December 4, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

BE (7); CN (17); BU (5); IT (6); PT (12); SE (1); ZA (7); TU (7); CR (5); IN (23); TW (5); US (110); RO (6); FI (6); AU (10); NO (7); PR (2); RU (7); ME (3); KR (13); PL (4); JP (18)