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 (COMBINE 1)

March 19, 2024 updated by: Novo Nordisk A/S

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.

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.

Study Overview

Status

Active, not recruiting

Study Type

Interventional

Enrollment (Estimated)

1290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Clinical Research
      • Kotara, New South Wales, Australia, 2289
        • Novatrials
      • Wollongong, New South Wales, Australia, 2500
        • Illawarra Diabetes Service Clinical Trials & Research Unit
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine Services
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Barwon Health (The Geelong Hospital)
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis - Bonheiden - Department of Endocrinology
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis Brussel - Diabeteskliniek
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
      • Edegem, Belgium, 2650
        • UZA - UZ Antwerpen - Department of Endocrinology
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
      • Leuven, Belgium, 3000
        • UZ Leuven - Endocrinology
      • Burgas, Bulgaria, 8000
        • "IPSMC - d-r Nikolay Kostadinov" EOOD
      • Kyustendil, Bulgaria, 2500
        • 'Medical center Medi city 21' OOD
      • Pleven, Bulgaria, 5801
        • DCC I- Pleven EOOD
      • Plovdiv, Bulgaria, 4001
        • UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
      • Sofia, Bulgaria, 1606
        • MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui provincial hospital
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
    • Chongqing
      • ChongQing, Chongqing, China, 404000
        • Chongqing University Three Gorges Hospital
    • Guangdong
      • Huizhou, Guangdong, China, 516001
        • Huizhou Central People's Hospital
    • Hebei
      • Hengshui, Hebei, China, 053000
        • Harrison International Peace Hospital
    • Henan
      • Kaifeng, Henan, China, 450000
        • Huaihe Hospital of Henan University
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • The First People's Hospital of Changzhou
      • Changzhou, Jiangsu, China, 213003
        • Changzhou No.2 People's Hospital, Yanghu Branch
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University_Nanjing
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
      • Zhenjiang, Jiangsu, China, 212001
        • The Affiliated Hospital of Jiangsu University_Zhenjiang
    • Shandong
      • Ji'nan, Shandong, China, 250013
        • Jinan Central Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200240
        • Shanghai Fifth People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • General Hospital of Tianjin Medical University
      • Tianjin, Tianjin, China, 300211
        • The Second Hospital of Tianjin Medical University
      • Osijek, Croatia, 31 000
        • Klinicki bolnicki centar Osijek
      • Pula, Croatia, 52100
        • Opca bolnica Pula
      • Rijeka, Croatia, 51000
        • KBC Rijeka, Endokrinologija
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed
    • Osječko - Baranjska Županija
      • Osijek, Osječko - Baranjska Županija, Croatia, 31000
        • Poliklinika SLAVONIJA OSIJEK
      • Kuopio, Finland, 70210
        • Health Step Finland Oy
      • Raisio, Finland, 21200
        • Raision sosiaali- ja terveyskeskus
      • Tampere, Finland, 33900
        • Tampereen diabetesvastaanotto
      • Turku, Finland, 20520
        • Turku University Hospital
      • Ähtäri, Finland, 63700
        • Ähtärin terveysasema
      • New Delhi, India, 110001
        • Lady Hardinge Medical College
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Gujarat Endocrine Centre
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Government Medical College, Kozhikode
      • Thriruvananthapuram, Kerala, India, 695 032
        • Jothydev's Diabetes & Research Center
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Kolhapur, Maharashtra, India, 416008
        • Excel Endocrine Centre
      • Mumbai, Maharashtra, India, 400012
        • Seth GS medical college and KEM Hospital
      • Mumbai, Maharashtra, India, 400008
        • BYL Nair Hospital and T N Medical College Department of endo
    • Orissa
      • Cuttack, Orissa, India, 753007
        • S.C.B. Medical College
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Post Graduate Institute of Medical Education & Research
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College & Hospital_Ludhiana
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 013
        • M.V.Hospital for Diabetes Pvt. Ltd.
      • Madurai, Tamil Nadu, India, 625020
        • Arthur Asirvatham hospital,
    • Telangana
      • Hyderabad, Telangana, India, 500072
        • Ramdev Rao Hospital
    • Telengana
      • Hyderabad, Telengana, India, 500 012
        • Osmania General Hospital
      • Catanzaro, Italy, 88100
        • Policlinico Mater Domini Università di Catanzaro
      • Chiavari (genova), Italy, 16034
        • ASL 4 Chiavarese
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
    • BA
      • Bari, BA, Italy, 70124
        • A.O.U. Consorziale Policlinico di Bari
      • Arakawa-ku, Tokyo, Japan, 116-0012
        • Kumanomae Nishimura Internal Medical Clinic
      • Chiba-shi, Chiba, Japan, 260-0804
        • Akaicho Clinic
      • Fukuoka-shi, Fukuoka, Japan, 819-0006
        • Futata Tetsuhiro Clinic Meinohama
      • Fukuoka-shi, Fukuoka, Japan, 819-0168
        • Kunisaki Makoto Clinic
      • Hokkaido, Japan, 062-0007
        • Sasaki Hospital Internal Medicine
      • Kumamoto, Japan, 861-8039
        • Yoshimura clinic
      • Saga-shi, Saga, Japan, 840-0937
        • Hisatomi Clinic
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Tokyo, Japan, 104-0031
        • Fukuwa Clinic
      • Yokohama-shi, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital, Endocrinology, Metabolism
    • Fukushima, Japan
      • Koriyama-shi, Fukushima, Japan, Japan, 963-8851
        • Seino Internal Medicine Clinic
    • Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan, 060-0062
        • Manda Memorial Hospital
    • Kanagawa, Japan
      • Chigasaki-shi, Kanagawa, Japan, Japan, 253-0044
        • Hayashi Diabetes Clinic
      • Chigasaki-shi, Kanagawa, Kanagawa, Japan, Japan, 253-0044
        • Hayashi Diabetes Clinic
    • Kumamoto, Japan
      • Kumamoto-shi, Kumamoto, Japan, Japan, 862-0976
        • Jinnouchi Hospital
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan, 880-0034
        • Heiwadai Hospital
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital_Seongnam-si
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 06591
        • Seoul Saint Mary's Hospital
      • Seoul, Korea, Republic of, 139-827
        • Nowon Eulji Medical Center, Eulji University
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 31151
        • Soonchunhyang University Hospital
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Aguascalientes, Mexico, 20230
        • Centro de Investigación Cardiometabólica de Aguascalientes
      • Mexico City, Mexico, 03300
        • Clínicos Asociados BOCM, S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. José Eleuterio González_Monterrey
      • Bodø, Norway, 8005
        • Nordlandssykehuset Bodø
      • Drammen, Norway, 3004
        • Drammen sykehus - Vestre Viken HF
      • Hamar, Norway, 2318
        • Sykehuset Innlandet HF Hamar
      • Oslo, Norway, 0586
        • Oslo universitetssykehus Aker
      • Trondheim, Norway, NO-7030
        • St. Olavs Hospital HF
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne (UCK)
      • Lublin, Poland, 20-044
        • NZOZ "CenterMed Lublin" Sp. z o.o.
      • Warszawa, Poland, 02-507
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
    • Lubelski
      • Lublin, Lubelski, Poland, 20-538
        • NZOZ Przychodnia Specjalistyczna Medica
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta
      • Aveiro, Portugal, 3814-501
        • Hospital Infante D. Pedro - Aveiro
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz
      • Lisboa, Portugal, 1349-019
        • Centro Hospitalar Lisboa Ocidental
      • Matosinhos, Portugal, 4464-513
        • Unidade Local de Saúde de Matosinhos
      • Vila Nova de Gaia, Portugal, 4400-346
        • Hospital da Luz Arrabida
      • Bayamon, Puerto Rico, 00961
        • Advanced Clinical Research LLC
      • Manati, Puerto Rico, 00674
        • Manati Ctr For Clin Research
      • Brasov, Romania, 500101
        • Mariodiab Clinic SRL
      • Iasi, Romania, 700547
        • SC Consultmed SRL
      • Satu-Mare, Romania, 440055
        • Clinica Korall S.R.L. Satu Mare
      • Suceava, Romania, 720237
        • Hospital Sf. Ioan cel Nou
    • Bucurestii
      • Bucharest, Bucurestii, Romania, 020475
        • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
    • Maramures
      • Baia Mare, Maramures, Romania, 430222
        • CMI Diabet, Nutritie, Boli Metabolice "Dr Pop Lavinia"
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Clinical Hospital
      • Ekaterinburg, Russian Federation, 620102
        • Sverdlovsk Regional Clinical Hospital #1
      • Irkutsk, Russian Federation, 664049
        • Irkutsk State Medical Academy of Postgraduate Education
      • Kursk, Russian Federation, 305016
        • Limited Liability Company "AriVa-Med"
      • Saint-Petersburg, Russian Federation, 194354
        • City Consultative & Diagnostic Centre #1
      • Saratov, Russian Federation, 410053
        • Saratov Regional Clinical Hospital
    • Russia
      • Tumen, Russia, Russian Federation, 625023
        • Tumen State Medical University
      • Belgrade, Serbia, 11000
        • Endocrinology, Diabetes and Metabolism Diseases Clinic
      • Alberton, South Africa, 1449
        • Netcare Alberton Hospital
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1820
        • Deepak Lakha
      • Johannesburg, Gauteng, South Africa, 1827
        • Hemant Makan
      • Johannesburg, Gauteng, South Africa, 2013
        • Wits Bara Clinical Trial Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Dr Pillay's Rooms
    • North West
      • Brits, North West, South Africa, 0250
        • Armansis Medical Centre
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7572
        • Langeberg Clinical Trials
      • Changhua City, Taiwan, 500
        • Changhua Christian Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Tainan City, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan City, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei city, Taiwan, 110
        • Taipei Medical University Hospital
      • Adana, Turkey, 01150
        • Cukurova Universitesi Tip Fakultesi
      • Ankara, Turkey, 06010
        • Gulhane Egitim Arastirma Hastanesi
      • Istanbul, Turkey, 34098
        • Haseki Sultangazi
      • Istanbul, Turkey, 34722
        • T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
      • Istanbul, Turkey, 34899
        • T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi
      • Tekirdag, Turkey, 59030
        • Tekirdag Namık Kemal UTF
    • Altindag
      • Ankara, Altindag, Turkey, 06230
        • Ankara Universitesi Ibni Sina Hastanesi
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Pri Med Grp dba/Gil Ctr Fam
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Medical Investigations, Inc.
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network
      • Escondido, California, United States, 92025
        • Headlands Research California, LLC
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • Lomita, California, United States, 90717
        • Torrance Clin Res Inst, Inc.
      • Los Alamitos, California, United States, 90720
        • Pacific Clinical Studies
      • Los Angeles, California, United States, 90017
        • Downtown LA Res Ctr. Inc.
      • Los Angeles, California, United States, 90057
        • Velocity Clin Res Wstlke
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • San Ramon, California, United States, 94583
        • NorCal Endocrinology and Internal Medicine
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Denver, Colorado, United States, 80246
        • Creekside Endocrine Associates, PC
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Res Of W Florida Inc
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc._New Port Richey
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute Inc
    • Georgia
      • Albany, Georgia, United States, 31707
        • Javara/Privia Med Grp GA,LLC
      • Fayetteville, Georgia, United States, 30214
        • Javara Inc.
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Assoc. LLC
    • Illinois
      • Skokie, Illinois, United States, 60077
        • NorthShore Univ Hlth Sys
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clin Research Ctr
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • New Orleans Center for Clinical Research
      • Slidell, Louisiana, United States, 70461-4231
        • Ileana J Tandron APMC
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Hlth Res Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5804
        • Brigham & Women's Hospital
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Hlth Ctr, PC
      • Flint, Michigan, United States, 48532
        • Elite Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group, PC
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Phys. Clinic
      • Omaha, Nebraska, United States, 68198
        • University of NE Med Ctr
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc.
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Southern New Hampshire Diabete
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clin Trials, Inc.
    • New York
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research, PLLC
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group, LLP
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences LLC
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Central Ohio Clinical Research LLC
      • Wadsworth, Ohio, United States, 44281
        • New Venture Medical Research
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes And Endocrinology Center
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group_Bristol
      • Morristown, Tennessee, United States, 37813
        • HealthStar Physicians PC
    • Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo Med Spec LLP
      • Austin, Texas, United States, 78731
        • Texas Diabetes & Endocrinology, P.A._Austin
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology, P.A._Austin
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75390-9302
        • Univ of TX SW Med Ctr Dallas
      • Houston, Texas, United States, 77024
        • Primecare Medical Group
      • Houston, Texas, United States, 77054
        • Javara Inc. / Privia Medical Group Gulf Coast PLLC
      • Houston, Texas, United States, 77079
        • PlanIt Research, PLLC
      • Hurst, Texas, United States, 76054
        • Protenium Clinical Research
      • Laredo, Texas, United States, 78041
        • Milton Haber, M.D.
      • Laredo, Texas, United States, 78041
        • Andres Garcia-Zuniga, MD, P.A
      • Longview, Texas, United States, 75605
        • DCOL Ctr for Clin Res
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocinology
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • San Antonio, Texas, United States, 78224
        • Briggs Clinical Research, LLC
      • San Marcos, Texas, United States, 78666
        • Javara Inc Privia Grp Gulf Cst
      • Sugar Land, Texas, United States, 77478
        • SimCare, PLLC
    • Virginia
      • Forest, Virginia, United States, 24551
        • Javara Inc/Privia Md GpLLC Fst
      • Norfolk, Virginia, United States, 23510
        • Eastern Virginia Medical School
      • Winchester, Virginia, United States, 22601
        • Amherst Family Practice P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key inclusion criteria

  1. Male or female and age above or equal to 18 years at the time of signing informed consent.
  2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
  3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
  4. 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.
  5. 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.

Key exclusion criteria

  1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  2. 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).
  3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
  4. Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening.
  5. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
  6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
  7. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
  8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
  9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IcoSema
Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Active Comparator: Insulin icodec
Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline week 0 (V2) to week 52 (V54)
% point
From baseline week 0 (V2) to week 52 (V54)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: From baseline week 0 (V2) to week 52 (V54)
Kg
From baseline week 0 (V2) to week 52 (V54)
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Time Frame: From baseline week 0 (V2) to week 57 (V56)
Number of episodes
From baseline week 0 (V2) to week 57 (V56)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Clinical Transparency (Dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

March 21, 2024

Study Completion (Estimated)

April 25, 2024

Study Registration Dates

First Submitted

April 24, 2022

First Submitted That Met QC Criteria

April 24, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • NN1535-4591
  • U1111 1260 8259 (Other Identifier: World Health Organization (WHO))
  • 2020 005281 34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on IcoSema

3
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