AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT05013229

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)

A Phase 3 study testing IcoSema, Insulin glargine and insulin aspart in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 182 sites in 14 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 glargine taken daily with insulin aspart 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… 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, Insulin glargine and insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
679 participants
Where
182 sitesin 14 countries
Study dates
30 Nov 2021to 14 Nov 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 percentage (53.- 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 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 90 days or more before screening:
  • Metformin
  • Sulfonylureas(a)
Show all 14Show fewer
  • 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) less than or equal to 40.0 kg/m^2.
  • 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 of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records.
  • 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

182 sites in 14 countries.

182 sites in 14 countries

United States66 sites

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106

  • AM Diabetes And Endocrinology Center

    Bartlett, Tennessee, 38133

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • 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

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • Creekside Endocrine Associates

    Denver, Colorado, 80209

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Valley Research

    Fresno, California, 93720

  • Physicians East Endocrinology

    Greenville, North Carolina, 27834

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama, 35976

  • Sweet Hope Research Specialty

    Hialeah, Florida, 33016

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • MedStar Hlth Res Institute

    Hyattsville, Maryland, 20782

  • E Coast Inst for Rsrch LLC_Jacksonville

    Jacksonville, Florida, 32204

  • Northeast Res Inst. Inc.

    Jacksonville, Florida, 32204

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • Scripps Wht Diab Inst La Jolla

    La Jolla, California, 92037

  • Andres Garcia-Zuniga, MD, P.A

    Laredo, Texas, 78041

  • Palm Research Center Inc-Vegas

    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

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • Downtown LA Res Ctr. Inc.

    Los Angeles, California, 90017

  • ActivMed Practice & Research LLC

    Methuen, Massachusetts, 01844

  • Ascension Medical Group- Germantown Clinic

    Milwaukee, Wisconsin, 53211

  • South Broward Research LLC

    Miramar, Florida, 33027

  • 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 NH Diabetes and Endocrinology

    Nashua, New Hampshire, 03060

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Mid Hudson Med Res-New Windsor

    New Windsor, New York, 12553

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York, 11758-1802

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020

  • Florida Inst For Clin Res

    Orlando, Florida, 32825

  • Clinical Investigations Of Texas

    Plano, Texas, 75075

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076

  • Briggs Clinical Research, LLC

    San Antonio, Texas, 78224

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233

  • San Diego Family Care

    San Diego, California, 92111

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Endeavor Health

    Skokie, Illinois, 60077

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478

  • Cotton-O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • New Venture Medical Research

    Wadsworth, Ohio, 44281

  • 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

  • Accellacare

    Wilmington, North Carolina, 28401

  • Amherst Family Practice P.C.

    Winchester, Virginia, 22601

Other trials in United States

India19 sites

  • Apollo Hospital, Ahmedabad

    Ahmedabad, Gujarat, 382428

  • Swasthya Diabetes Care

    Ahmedabad, Gujarat, 390013

  • Swasthya Diabetes Care

    Ahmedabad, 390013

  • Diacon Hospital Private Limited

    Bangalore, Karnataka, 560010

  • Post Graduate Institute of Medical Education & Research

    Chandigarh, Punjab, 160012

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Apollo Hospital International Ltd

    Gandhinagar, Gujarat, 382428

  • Nizams Institute of Medical Science

    Hyderabad, Telangana, 500082

  • Yashoda hospital

    Hyderabad, Telangana, 500082

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh, 452010

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • Medanta Lucknow Hospital

    Lucknow, Uttar Pradesh, 226030

  • Christian Medical College and Hospital

    Ludhiana, Punjab, 141008

  • Fortis Heart Institute and Multispeciality Hospital

    Mohali, Punjab, 160062

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411004

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004

  • chelleram Diabetes Institute

    Pune, Maharashtra, 411021

  • Sree Gokulam Medical College & Research Foundation

    Trivandrum, Kerala, 695 607

  • Christian Medical College Hospital, Vellore

    Vellore, Tamil Nadu, 632004

Other trials in India

Czechia14 sites

  • Ambulance Brno s.r.o.

    Brno, 602 00

  • Fakultní nemocnice U sv. Anny v Brně

    Brno, 602 00

  • University Hospital U sv. Anny

    Brno, 656 91

  • Dum zdravi

    Hodonín, 695 01

  • FN Hradec Kralove

    Hradec Králové, 500 05

  • Klinika Dr. Pírka s.r.o.

    Mladá Boleslav, 29301

  • Fakultni nemocnice Plzen

    Pilsen, Czech Republic, 304 60

  • Fakultni nemocnice Plzen

    Pilsen, Czech Republic, 323 00

  • Diabet2 s.r.o.

    Prague, 110 00

  • Diabetologická a interní ambulance Diabet2

    Prague, 110 00

  • III. interni klinika VFN a 1. LK UK v Praze

    Prague, 12000

  • Institut klinicke a experimentalni mediciny_Praha

    Prague, 14021

  • Fledip s.r.o.

    Prague, 160 00

  • ResTrial s.r.o.

    Prague, 18100

Other trials in Czechia

Japan13 sites

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804

  • The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

    Chuo-ku, Tokyo, 103-0002

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Asano Clinic

    Kawagoe-shi, Saitama, Japan, 350-0851

  • Minami Akatsuka Clinic

    Mito-shi, Ibaraki, 311-4153

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034

  • Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.

    Osaka, 569-1045

  • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

    Shinjuku-ku, Tokyo, 1600023

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Fukuwa Clinic

    Tokyo, 104-0031

Other trials in Japan

Malaysia11 sites

  • Klinik Kesihatan Simpang Kuala

    Alor Star, 05400

  • Hospital Ampang

    Ampang, Selangor, 68000

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000

  • Hospital Universiti Kebangsaan Malaysia

    Cheras, Kuala Lumpur, 56000

  • Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan

    Kota Bharu, Kelantan, 16150

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

  • Miri Hospital

    Miri, Sarawak, 98000

  • Hospital Seri Manjung

    Seri Manjung, Perak, 32040

  • University Technology MARA (UiTM) - Puncak Alam

    Sungai Buloh, Selangor, 47000

  • University Technology MARA (UiTM) - Sg Buloh

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

Poland9 sites

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship, 15-879

  • SNZOZ Lege Artis

    Bialystok, 15-404

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-338

  • NBR Polska Tomasz Klodawski

    Warsaw, 00-710

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, 02-507

Other trials in Poland

France7 sites

  • Centre Hospitalier Departemental Vendee- La Roche Sur Yon

    La Roche-sur-Yon, 85295

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630

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

    Le Creusot, 71200

  • Centre Hospitalier de Narbonne

    Narbonne, 11108

  • Aphp-Hopital Lariboisiere-1

    Paris, 75010

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2

    Pessac, 33600

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Germany7 sites

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Plassmann

    Essen, 45359

  • Wendisch/Dahl Hamburg (DZHW)

    Hamburg, 22607

  • Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck

    Lübeck, 23538

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

    Münster, 48145

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758

  • Zentrum für klinische Studien Alexander Segner

    Saint Ingbert-Oberwürzbach, 66386

Other trials in Germany

Italy7 sites

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, CZ, 88100

  • Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea

    Cittadella, 35013

  • Azienda Ospedaliera Luigi Sacco

    Milan, 20157

  • Ospedale Civico Partinico di Palermo

    Partinico, 90047

  • Pol. Uni. Campus Biomedico

    Roma, RM, 00128

  • IRCCS Multimedica

    Sesto San Giovanni (MI), 20099

  • Ospedale San Bassiano

    Vicenza, 36061

Other trials in Italy

Thailand7 sites

  • King Chulalongkorn Memorial Hospital_Endocrinology

    Bangkok, 10330

  • Rajavithi Hospital_Diabetes and Endocrinology

    Bangkok, 10400

  • Siriraj Hospital_Dept Endocrinology

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital_Endocrilogy

    Chiang Mai, Mueang Chiang Mai District, 50200

  • Maharaj Nakorn Chiang Mai Hospital_Endocrilogy

    Chiang Mai, 50200

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Maharat Nakhon Ratchasima Hospital

    Nakhon Ratchasima, 30000

Other trials in Thailand

Turkey (Türkiye)7 sites

  • Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi

    Adana, 01250

  • Gulhane Egitim Arastirma Hastanesi

    Ankara, 06010

  • Akdeniz Üniversitesi Hastanesi- Endokrinoloji

    Antalya, 07058

  • Aydın Adnan Menderes Üniversitesi Hastanesi

    Aydin, 09010

  • Pamukkale Universitesi Tip Fakultesi

    Denizli, 20070

  • Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi- Endokrinoloji

    Istanbul, 34400

  • Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Endokrinoloji

    Izmir, 35340

Other trials in Turkey (Türkiye)

Hungary6 sites

  • Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház

    Békéscsaba, 5600

  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1036

  • Szőcs Depot Egészségügyi Szolgáltató Kft.

    Budapest, 1042

  • Semmelweis Egyetem II. Belgyógyászati Klinika

    Budapest, 1088

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089

  • Coromed SMO Kft.

    Pécs, 7623

Other trials in Hungary

Slovenia5 sites

  • Healthcare centre Kocevje

    Kočevje, 1330

  • Healthcare Centre Koper

    Koper, SI-6000

  • UKC Ljubljana, Endocrinology and Diabetes

    Ljubljana, SI-1000

  • General Hospital Murska Sobota

    Murska Sobota, SI-9000

  • General Hospital Nova Gorica_Diabetes

    Nova Gorica, SI-5290

Other trials in Slovenia

South Africa4 sites

  • Medi-Clinic Bloemfontein

    Bloemfontein, Free State, 9301

  • Spoke Research Inc

    Cape Town, Western Cape, 7441

  • Lenasia Clinical Trial Centre

    Lenasia, Gauteng, 1827

  • Prof P. Joshi

    Pretoria, Gauteng, 0181

Other trials in South Africa

About this study

Official title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart 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 glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.

Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines 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 be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Being tested
IcoSema, Insulin glargine, insulin aspart
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 a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.

  • Insulin glargineDrug

    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.

  • insulin aspartDrug

    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.

Study groups in NCT05013229
Study groupRoleWhat they receive
IcoSemaExperimentalParticipants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.
Receives: Drug: IcoSema
Insuling glargine/insulin aspartActive comparatorParticipants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.
Receives: Drug: Insulin glargine; Drug: insulin aspart

What is being measured

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

  1. Change in HbA1c

    Percent-points

    Measured: From baseline week 0 (V2) to week 52 (V54)

Secondary outcomes (10)

  1. Change in body weight

    Kg

    Measured: From baseline week 0 (V2) to week 52 (V54)

  2. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)

    Number of episodes

    Measured: From week 0 (V52) to week 52 (V54)

  3. Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6

    Percentage of readings

    Measured: From week 48 (V50) to week 52 (V54)

  4. Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6

    Percentage of readings

    Measured: From week 48 (V50) to week 52 (V54)

  5. Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6

    Percentage of readings

    Measured: From week 48 (V50) to week 52 (V54)

  6. Change in fasting plasma glucose (FPG)

    mmol/L

    Measured: From baseline week 0 (V2) to week 52 (V54)

  7. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction

    Score 0-36. The higher the score the greater the satisfaction with treatment.

    Measured: From baseline week 0 (V2) to week 52 (V54)

  8. Number of severe hypoglycaemic episodes (level 3)

    Number of episodes

    Measured: From baseline week 0 (V2) to week 57 (V56)

  9. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter)

    Number of episodes

    Measured: From baseline week 0 (V2) to week 57 (V56)

  10. Weekly insulin dose (total)

    Units

    Measured: From week 50 (V52) to week 52 (V54)

Timeline

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

  1. First posted19 Aug 2021
  2. Study start30 Nov 2021
  3. Primary completion14 Nov 2023
  4. Study completion14 Nov 2023

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
679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05013229
Sponsor's protocol ID
NN1535-4593
Other IDs
U1111-1260-8295, 2020-005309-18, jRCT2051210127
Status last verified
Nov 2025
First submitted
13 Aug 2021
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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

  • Billings LK, Andreozzi F, Frederiksen M, Gourdy P, Gowda A, Ji L, Pletsch-Borba L, Suzuki R, Unnikrishnan AG, Vianna AGD. Once-weekly IcoSema versus multiple daily insulin injections in type 2 diabetes management (COMBINE 3): an open-label, multicentre, treat-to-target, non-inferiority, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):556-567. doi: 10.1016/S2213-8587(25)00052-X. Epub 2025 Jun 4.

    PubMed 40482670

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IcoSema, Insulin glargine and insulin aspart in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 182 sites in 14 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 14 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 2 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 182 sites in United States, India, Czechia, Japan, Malaysia and 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 HbA1c (time frame: From baseline week 0 (V2) to week 52 (V54)). 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 NCT05013229, 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 2 Dec 2025.

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