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 Semaglutide (COMBINE 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

683

Participants

Timeline

Start Date

April 11, 2022

Primary Completion Date

December 13, 2023

Study Completion Date

January 16, 2024

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

IcoSema

"IcoSema once weekly subcutaneously (s.c., under the skin) using a needle and a pen.~For about 1 year and 1 month."

DRUG

Semaglutide 1 mg

Semaglutide once weekly subcutaneously (s.c., under the skin). Dose titrated to 1mg over 8 weeks (0.25 mg for 4 weeks, 0.5 mg for 4 weeks). For about 1 year and 1 month.

Trial Locations (136)

112

Taipei Veterans General Hospital, Taipei

333

Chang Gung Medical Foundation - Linkou Branch, Taoyuan District

402

Chung Shan Medical University Hospital, Taichung

704

National Cheng Kung University Hospital, Tainan City

710

Chi Mei Medical Center, Tainan City

1132

MED-TIMA Kft., Budapest

4032

Debreceni Egyetem Belgyógyászati Klinika, Debrecen

4600

Kantonsspital Olten, Olten

6000

Luzerner Kantonsspital, Lucerne

7623

PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum, Pécs

8125

Diabetes Adipositas Zentrum Zürich, Zollikerberg

10676

Evangelismos Hospital, Athens

14224

Southgate Medical Group, LLP, West Seneca

19107

Thomas Jefferson Univ Di Rsrch Ctr, Philadelphia

20782

MedStar Hlth Res Institute, Hyattsville

23606

TPMG Clinical Research, Newport News

24551

Javara Inc. / Privia Medical Group LLC_Forest, Forest

Javara Inc/Privia Md GpLLC Fst, Forest

27408

PharmQuest Life Sciences LLC, Greensboro

28630

Les Hopitaux de Chartres-Hopital Louis Pasteur, Le Coudray

29485

Palmetto Clinical Research, Summerville

31054

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2, Toulouse

31707

Javara/Privia Med Grp GA,LLC, Albany

32003

Northeast Research Institute, Fleming Island

32204

Northeast Res Inst. Inc., Jacksonville

32216

Est Cst Inst for Rsrch,Jksnvil, Jacksonville

32757

Adult Medicine of Lake County, Inc., Mt. Dora

32765

Oviedo Medical Research, LLC, Oviedo

32825

Florida Inst For Clin Res, Orlando

Florida Institute For Clinical Research, Orlando

33027

South Broward Research LLC, Miramar

33401

Metabolic Research Institute Inc, West Palm Beach

35152

Linn clinic - Clalit Health Services, Haifa

35294

Univ of AL at Birmingham_BRM, Birmingham

37404

Chattanooga Medical Research, LLC, Chattanooga

38133

AM Diabetes And Endocrinology Center, Bartlett

41110

Univ Gen Hospital Larisa, Larissa

44281

New Venture Medical Research, Wadsworth

Diabetes Clinic Meir MC, Kfar Saba

44718

Diab & Endo Assoc of Stark Co, Canton

44800

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1, Saint-Herblain

49620

Northern Pines Hlth Ctr, PC, Buckley

52621

Endrocrinolgy Clinic - Sheba Medical Center, Tel Litwinsky

54635

General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki

54642

"Ippokrateio G.H. of Thessaloniki", Thessaloniki

57001

"Thermi Private Hosital", Thessaloniki

57010

"General Hospital of Thessaloniki G.Papanikolaou", Thessaloniki

58100

Diabetes Clinic Wolfson MC, Holon

60077

Endeavor Health, Skokie

69200

Centre de Recherche Clinique Portes Du Sud, Vénissieux

71200

Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1, Le Creusot

75231

North Texas Endocrine Center, Dallas

75605

DCOL Ctr for Clin Res, Longview

76132

Diabetes and Thyroid Ctr of FW, Fort Worth

76230

Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume, Bois-Guillaume

77479

Sugar Lakes Family Practice PA, Sugar Land

78233

NE Clin Res of San Antonio, San Antonio

78414

Osvaldo A. Brusco MD PA, Corpus Christi

78681

Texas Diabetes & Endocrinology_Round Rock, Round Rock

78731

Texas Diab & Endo, P.A., Austin

78749

Texas Diabetes & Endocrinology, Austin

79106

Amarillo Med Spec LLP, Amarillo

84790

Chrysalis Clinical Research, St. George

85296

Pri Med Grp dba/Gil Ctr Fam, Gilbert

85375

Clinical Research Institute of Arizona, Sun City West

87102

Albuquerque Clin Trials, Inc., Albuquerque

89148

Palm Research Center Inc-Vegas, Las Vegas

90017

Velocity Clin Res Los Angeles, Los Angeles

90057

Velocity Clin Res Wstlke, Los Angeles

91120

Diabetes Unit Hadassah Ein Karem MC, Jerusalem

91325

Valley Clinical Trials, Inc., Northridge

91602

Premier Medical Center, Inc., Toluca Lake

93401

DIA - KONTROL s.r.o., Levice

94520

John Muir Physicians Network, Concord

96814

East West Med Res Inst, Honolulu

100044

Peking University People's Hospital-Endocrinology, Beijing

117292

National Medical Research Center of Endocrinology, Moscow

200040

Huashan Hospital Fudan University-Endocrinology, Shanghai

Shanghai Huashan Hospital, Affiliated to Fudan University, Shanghai

200240

Shanghai Fifth People's Hospital-Endocrinology, Shanghai

210011

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing

213003

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

230001

Anhui Provincial Hospital-Endocrinology, Hefei

250013

Jinan Central Hospital, Ji'nan

300052

General Hospital of Tianjin Medical University-Endocrinology, Tianjin

300070

Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology, Tianjin

344022

Rostov State Medical University_Rostov-on-Don, Rostov-on-Don

404000

Chongqing University Three Gorges Hospital, Chongqing

424004

Polyclinic #2 in Yoshkar-Ola, Yoshkar-Ola

440052

Penza Regional Clinical Hospital named after N.N. Burdenko, Penza

516001

Huizhou Central People's Hospital-Endocrinology, Huizhou

630099

"Limited Law Company Healthy Family Medicine Center", Novosibirsk

644029

"BHI of Omsk Region City Hospital № 3", Omsk

664049

Irkutsk State Medical Academy of Postgraduate Education, Irkutsk

4630945

Clalit sick fund Herzeliya, Herzeliya

83686-6011

Saltzer Medical Group Research, Nampa

70461-4231

Ileana J Tandron APMC, Slidell

08648

John J Shelmet, MD, Lawrenceville

75390-9302

UT Southwestern Med Cntr, Dallas

60150-162

Centro de Diabetes Metabolismo e Endocrinologia, Fortaleza

74935-530

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas, Aparecida de Goiânia

80045-110

Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV, Curitiba

80810-040

Centro de Diabetes Curitiba, Curitiba

12243-280

Instituto São José dos Campos em Pesquisas Médicas, São José dos Campos

01236-030

BR Trials - Ensaios Clínicos e Consultoria Ltda., São Paulo

L4K 4M2

LMC Clinical Res Thornhill, Concord

L1E2J5

Medical Trust Clinics, Inc., Courtice

L8L 5G8

Wharton Med Clin Trials, Hamilton

N6G 2M1

Western Univ. Cnt for Studies in Fam Med, London

N7T 4X3

Bluewater Clin Res Group,Inc, Sarnia

M4G 3E8

LMC Endo Centres Ltd.(Bayview), Toronto

H1M 1B1

Recherche GCP Research, Montreal

H1Y 3H5

Recherche GCP Research, Montreal

H4T 1Z9

LMC Clin Rsrch Inc. (Montreal), Montreal

LMC Clin Rsrch Inc. (Montreal), Saint-Laurent

G1G 3Y8

Recherche Clinique Sigma inc, Québec

115 25

Iatriko Psychicou Private Clinic, Athens

115 27

'G. Gennimatas' General Hospital of Athens, Athens

H-4043

Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület, Debrecen

880-0034

Heiwadai Hospital, Miyazaki

103-0002

The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo

819-0006

Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka

501-1194

Gifu University Hospital, Gifu

311-0113

Naka Kinen Clinic, Ibaraki

569-1045

Takatsuki Red Cross Hospital, Osaka

336-0967

Shimizu Clinic Fusa, Saitama

340-0015

Soka Sugiura Internal Medicine Clinic_Internal Medicine, Saitama

983-0039

Shinden Higashi Clinic, Sendai-shi, Miyagi

040 01

DIOLI s.r.o., Košice

HUMAN-CARE s.r.o., Košice

04011

DIADAN, s.r.o. Kosice, Košice

04190

FNsP L. Pasteura, Košice

039 01

MUDr. Alena Lomencikova, s.r.o, Turčianske Teplice

413 46

Primary Care Trial Center, PTC ,Gothia Forum, Gothenburg

703 62

Enheten för Kliniska Studier (EKS), Örebro, Örebro

113 65

Centrum for Diabetes, Academical Specialist Centrum, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT05259033 - 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 Semaglutide (COMBINE 2) | Biotech Hunter | Biotech Hunter