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 Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

PHASE3CompletedINTERVENTIONAL
Enrollment

679

Participants

Timeline

Start Date

November 30, 2021

Primary Completion Date

November 14, 2023

Study Completion Date

November 14, 2023

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

IcoSema

Participants will receive a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.

DRUG

Insulin glargine

Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.

DRUG

insulin aspart

Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.

Trial Locations (131)

1036

Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest

1042

Szőcs Depot Egészségügyi Szolgáltató Kft., Budapest

1088

Semmelweis Egyetem II. Belgyógyászati Klinika, Budapest

1089

ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest

1330

Healthcare centre Kocevje, Kočevje

1827

Lenasia Clinical Trial Centre, Lenasia

5600

Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház, Békéscsaba

7441

Spoke Research Inc, Cape Town

9301

Medi-Clinic Bloemfontein, Bloemfontein

10400

Rajavithi Hospital, Bangkok

10700

Siriraj Hospital_Bangkoknoi, Bangkok, Bangkoknoi, Bangkok

12000

III. interni klinika VFN a 1. LK UK v Praze, Prague

14021

Institut klinicke a experimentalni mediciny_Praha, Prague

14224

Southgate Medical Group, LLP, West Seneca

16150

Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan, Kota Bharu

18100

ResTrial s.r.o., Prague

20070

Pamukkale Universitesi Tip Fakultesi, Denizli

20099

IRCCS Multimedica, Sesto San Giovanni (MI)

20157

Azienda Ospedaliera Luigi Sacco, Milan

20782

MedStar Hlth Res Institute, Hyattsville

22607

Wendisch/Dahl Hamburg, Hamburg

23758

RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein

28401

Accellacare, Wilmington

28625

Piedmont Healthcare/Research, Statesville

30000

Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima

30076

Endo Res Solutions Inc, Roswell

32003

Northeast Research Institute, Fleming Island

32040

Hospital Seri Manjung, Seri Manjung

32204

Northeast Res Inst. Inc., Jacksonville

32757

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

32825

Florida Inst For Clin Res, Orlando

33027

South Broward Research LLC, Miramar

33600

Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2, Pessac

34400

TC SB Ist.İl Sag.Müd.Prof.Dr.Cemil Tascioglu Sehir Hastanesi, Istanbul

35340

Dokuz Eylul University Medical Faculty, Izmir

37411

Univ Diab & Endo Consultants, Chattanooga

37813

HealthStar Physicians PC, Morristown

38133

AM Diabetes And Endocrinology Center, Bartlett

40002

Srinagarind Hospital, Khon Kaen

40503

The Research Group of Lexington LLC, Lexington

44281

New Venture Medical Research, Wadsworth

44718

Diab & Endo Assoc of Stark Co, Canton

45005

Prestige Clinical Research, Franklin

45136

InnoDiab Forschung GmbH, Essen

47000

University Technology MARA (UiTM) - Puncak Alam, Sungai Buloh

University Technology MARA (UiTM) - Sg Buloh, Sungai Buloh

48145

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster

49620

Northern Pines Hlth Ctr, PC, Buckley

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

50265

Iowa Diab & Endo Res Center, West Des Moines

56000

Hospital Universiti Kebangsaan Malaysia, Cheras

59100

University Malaya Medical Centre, Kuala Lumpur

60077

Endeavor Health, Skokie

66386

Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach

69200

Centre de Recherche Clinique Portes Du Sud, Vénissieux

71200

Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2, Le Creusot

75010

Aphp-Hopital Lariboisiere-1, Paris

75075

Clinical Investigations Of Texas, Plano

75230

Velocity Clinical Res-Dallas, Dallas

76054

Protenium Clinical Research, Hurst

77079

PlanIt Research, PLLC, Houston

77478

Simcare Medical Research, LLC, Sugar Land

78041

Andres Garcia-Zuniga, MD, P.A, Laredo

78224

Briggs Clinical Research, LLC, San Antonio

78233

NE Clin Res of San Antonio, San Antonio

79106

Amarillo Med Spec LLP, Amarillo

80209

Creekside Endocrine Associates, Denver

84790

Chrysalis Clinical Research, St. George

85295

Centre Hospitalier Departemental Vendee- La Roche Sur Yon, La Roche-sur-Yon

88100

Azienda Ospedaliero-Universitaria Renato Dulbecco, Catanzaro

89148

Palm Research Center Inc-Vegas, Las Vegas

90017

Downtown LA Res Ctr. Inc., Los Angeles

90047

Ospedale Civico Partinico di Palermo, Partinico

92037

Scripps Wht Diab Inst La Jolla, La Jolla

92111

San Diego Family Care, San Diego

98000

Miri Hospital, Miri, Sarawak

98057

Rainier Clin Res Ctr Inc, Renton

141008

Christian Medical College and Hospital, Ludhiana

160012

Post Graduate Institute of Medical Education & Research, Chandigarh

160062

Fortis Heart Institute and Multispeciality Hospital, Mohali

226030

Medanta Lucknow Hospital, Lucknow

302006

Diabetes, Thyroid and Endocrine Centre, Jaipur

382428

Apollo Hospital, Ahmedabad, Ahmedabad

Apollo Hospital International Ltd, Gandhinagar

390013

Swasthya Diabetes Care, Ahmedabad

411004

Sahyadri Speciality Hospital, Pune

Sahyadri Super Speciality Hospital, Pune

411021

chelleram Diabetes Institute, Pune

452010

TOTALL Diabetes Hormone Institute, Indore

560010

Diacon Hospital Private Limited, Bangalore

600086

Madras Diabetes Research Foundation, Chennai

632004

Christian Medical College Hospital, Vellore, Vellore

1600023

Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology, Shinjuku-ku

83686-6011

Saltzer Medical Group Research, Nampa

03060

Southern NH Diabetes and Endocrinology, Nashua

29681-1538

Hillcrest Clinical Research, Simpsonville

304 60

Fakultni nemocnice Plzen, Pilsen

323 00

Fakultni nemocnice Plzen, Pilsen

602 00

University Hospital U sv. Anny, Brno

656 91

University Hospital U sv. Anny, Brno

500 05

FN Hradec Kralove, Hradec Králové

110 00

Diabet2 s.r.o., Prague

Diabetologická a interní ambulance Diabet2, Prague

160 00

Fledip s.r.o., Prague

00128

Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia, Roma

880-0034

Heiwadai Hospital, Miyazaki

350-0851

Asano Clinic, Kawagoe-shi

468-0009

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology, Aichi

260-0804

Akaicho Clinic, Chiba-shi, Chiba

103-0002

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

311-0113

Naka Kinen Clinic, Ibaraki

311-4153

Minami Akatsuka Clinic, Mito-shi, Ibaraki

569-1045

Takatsuki Red Cross Hospital, Osaka

103-0027

Tokyo-Eki Center-building Clinic, Tokyo

104-0031

Fukuwa Clinic, Tokyo

05400

Klinik Kesihatan Simpang Kuala, Alor Star

15-435

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok

81-338

Centrum Medyczne Pratia Gdynia, Gdynia

15-404

SNZOZ Lege Artis, Bialystok

90-132

Gabinet Lekarski Malgorzata Saryusz-Wolska, Lodz

90-338

Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz

00-710

NBR Polska Tomasz Klodawski, Warsaw

SI-6000

Healthcare Centre Koper, Koper

SI-1000

UKC Ljubljana, Endocrinology and Diabetes, Ljubljana

SI-9000

General Hospital Murska Sobota, Murska Sobota

SI-5290

General Hospital Nova Gorica_Diabetes, Nova Gorica

0181

Prof P. Joshi, Pretoria

01250

Baskent Universitesi Adana, Adana

06010

Gulhane Egitim Arastirma Hastanesi, Ankara

07058

Akdeniz University Tip Fakultesi Hastanesi, Antalya

09010

Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi, Aydin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT05013229 - 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 Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3) | Biotech Hunter | Biotech Hunter