A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

Last updated: August 29, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes Prevention

Treatment

Insulin glargine

Insulin icodec

Clinical Study ID

NCT06340854
NN1436-7724
2023-506084-34
U1111-1292-6151
  • Ages > 18
  • All Genders

Study Summary

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening.

  • HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed bycentral laboratory analysis.

  • Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorninsulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulinglargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any ofthe following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides),Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oralcombination products (for the allowed individual oral anti- diabetic drugs), oral orinjectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectableglucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptidereceptor agonist (GIP RA) combination products.

  • Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m^2).

Exclusion

Exclusion Criteria:

  • Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.

  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris ortransient ischaemic attack within 180 days prior to the day of screening.

  • Chronic heart failure classified as being in New York Heart Association Class IV atscreening.

  • Anticipated initiation or change in concomitant medications (for more than 14consecutive days) known to affect weight or glucose metabolism (e.g., treatment withorlistat, thyroid hormones, or corticosteroids).

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within the past 90 days prior to screening or inthe period between screening and randomisation. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination.

Study Design

Total Participants: 429
Treatment Group(s): 2
Primary Treatment: Insulin glargine
Phase: 3
Study Start date:
April 19, 2024
Estimated Completion Date:
June 13, 2025

Connect with a study center

  • "Medical Center Viva Feniks" Ood

    Dobrich, 9300
    Bulgaria

    Site Not Available

  • "Medical Center Viva Feniks" Ood

    Dobrich 726418, 9300
    Bulgaria

    Site Not Available

  • MHAT "Knyaginya Klementina" -Sofia EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Medical Institute of Ministry of interior

    Sofia, 1606
    Bulgaria

    Site Not Available

  • UMHAT Aleksandrovska

    Sofia, 1431
    Bulgaria

    Site Not Available

  • MHAT "Knyaginya Klementina" -Sofia EAD

    Sofia 727011, 1233
    Bulgaria

    Site Not Available

  • Medical Institute of Ministry of interior

    Sofia 727011, 1606
    Bulgaria

    Site Not Available

  • UMHAT Aleksandrovska

    Sofia 727011, 1431
    Bulgaria

    Site Not Available

  • Medical centre Clinic Nova

    Varna, 9000
    Bulgaria

    Site Not Available

  • Medical centre Clinic Nova

    Varna 726050, 9000
    Bulgaria

    Site Not Available

  • Medical centre Berbatov Beli drin

    Yambol, 8600
    Bulgaria

    Site Not Available

  • Medical centre Berbatov Beli drin

    Yambol 725578, 8600
    Bulgaria

    Site Not Available

  • InnoDiab Forschung GmbH

    Essen, 45136
    Germany

    Site Not Available

  • InnoDiab Forschung GmbH

    Essen 2928810, 45136
    Germany

    Site Not Available

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

    Münster, 48145
    Germany

    Site Not Available

  • MedicalCenter am Clemenshospital

    Münster, 48153
    Germany

    Site Not Available

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153
    Germany

    Site Not Available

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

    Münster 2867543, 48145
    Germany

    Site Not Available

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster 2867543, 48153
    Germany

    Site Not Available

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758
    Germany

    Site Not Available

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein 2857451, 23758
    Germany

    Site Not Available

  • Institut für Diabetesforschung Osnabrück

    Osnabrück, 49080
    Germany

    Site Not Available

  • Institut für Diabetesforschung Osnabrück

    Osnabrück 2856883, 49080
    Germany

    Site Not Available

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239
    Germany

    Site Not Available

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen 2814270, 88239
    Germany

    Site Not Available

  • Lifecare Hospital and Research Centre

    Bangalore, Karnataka 560092
    India

    Site Not Available

  • Belgaum Diabetes Centre

    Belgaum, Karnataka 590001
    India

    Site Not Available

  • Manipal Hospital, Old Airport Road, Bengaluru

    Bengaluru, Karnataka 560017
    India

    Site Not Available

  • Lifecare Hospital and Research Centre

    Bangalore 1277333, Karnataka 1267701 560092
    India

    Site Not Available

  • Belgaum Diabetes Centre

    Belagavi 1276533, Karnataka 1267701 590001
    India

    Site Not Available

  • Manipal Hospital, Old Airport Road, Bengaluru

    Bengaluru 1277333, Karnataka 1267701 560017
    India

    Site Not Available

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala 682041
    India

    Site Not Available

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh 452010
    India

    Site Not Available

  • TOTALL Diabetes Hormone Institute

    Indore 1269743, Madhya Pradesh 1264542 452010
    India

    Site Not Available

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra 400012
    India

    Site Not Available

  • Chellaram Diabetes Institute

    Pune, Maharashtra 411021
    India

    Site Not Available

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, Maharashtra 411001
    India

    Site Not Available

  • Seth GS Medical College & KEM Hospital

    Mumbai 1275339, Maharashtra 1264418 400012
    India

    Site Not Available

  • Chellaram Diabetes Institute

    Pune 1259229, Maharashtra 1264418 411021
    India

    Site Not Available

  • Grant Medical Foundation Ruby Hall Clinic

    Pune 1259229, Maharashtra 1264418 411001
    India

    Site Not Available

  • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

    Puducherry, Tamil Nadu 1255053 605006
    India

    Site Not Available

  • Malla Reddy Narayana Multispeciality Hospital

    Hyderabad, Telangana 500055
    India

    Site Not Available

  • Gandhi Hospital & Medical college

    Hyderabad 1269843, Telangana 1254788 500003
    India

    Site Not Available

  • Malla Reddy Narayana Multispeciality Hospital

    Hyderabad 1269843, Telangana 1254788 500055
    India

    Site Not Available

  • Gandhi Hospital & Medical college

    Hyderabad, Telengana 500003
    India

    Site Not Available

  • Government Institute of Medical Sciences

    Noida, Uttar Pradesh 201310
    India

    Site Not Available

  • Government Institute of Medical Sciences

    Noida 7279746, Uttar Pradesh 1253626 201310
    India

    Site Not Available

  • Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

    Chandigarh, 160012
    India

    Site Not Available

  • Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

    Chandigarh 1274746, 160012
    India

    Site Not Available

  • Christian Medical College and Hospital

    Ludhiana, 141008
    India

    Site Not Available

  • Christian Medical College and Hospital

    Ludhiana 1264728, 141008
    India

    Site Not Available

  • Heiwadai Hospital

    Miyazaki-shi, Miyazaki 880-0034
    Japan

    Site Not Available

  • Heiwadai Hospital_Internal Medicine

    Miyazaki 1856717, Miyazaki 1856710 880-0034
    Japan

    Site Not Available

  • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

    Shinjuku-ku, Tokyo 1600023
    Japan

    Site Not Available

  • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

    Shinjuku-ku, Tokyo 1850147, Tokyo 1850144 160-0023
    Japan

    Site Not Available

  • Futata Tetsuhiro Clinic Meinohama

    Fukuoka-shi, Fukuoka, 819-0006
    Japan

    Site Not Available

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006
    Japan

    Site Not Available

  • Oyama East Clinic

    Tochigi, 323-0022
    Japan

    Site Not Available

  • Oyama East Clinic_Internal Medicine

    Tochigi 1850311, 323-0022
    Japan

    Site Not Available

  • Noritake Clinic

    Ushiku-shi, Ibaraki, 300-1207
    Japan

    Site Not Available

  • Noritake Clinic

    Ushiku-shi, Ibaraki 1862033, 300-1207
    Japan

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole 3090048, Opole Voivodeship 3337495 45-401
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, Opolskie 45-401
    Poland

    Site Not Available

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie 15-435
    Poland

    Site Not Available

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship 15-879
    Poland

    Site Not Available

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok 776069, Podlaskie Voivodeship 858789 15-435
    Poland

    Site Not Available

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok 776069, Podlaskie Voivodeship 858789 15-879
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia 3099424, Pomeranian Voivodeship 3337496 81-338
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomorskie 81-338
    Poland

    Site Not Available

  • Trialmed CRS

    Piotrków Trybunalski, Łódzkie 97-300
    Poland

    Site Not Available

  • Trialmed CRS

    Piotrkow Trybunalski 3088972, Łódź Voivodeship 3337493 97-300
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice 3096472, 40-081
    Poland

    Site Not Available

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw 756135, 02-507
    Poland

    Site Not Available

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warszawa, 02-507
    Poland

    Site Not Available

  • Advanced Clinical Research LLC

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Advanced Clinical Research LLC

    Bayamón 4562831, 00959
    Puerto Rico

    Site Not Available

  • Manati Ctr For Clin Research

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Manati Ctr For Clin Research

    Manatí 4566137, 00674
    Puerto Rico

    Site Not Available

  • Hemant Makan

    Johannesburg, Gauteng 1827
    South Africa

    Site Not Available

  • Dr Moosa's Rooms

    Lenasia, Gauteng 1827
    South Africa

    Site Not Available

  • Botho ke Bontle Health Services

    Pretoria, Gauteng 0184
    South Africa

    Site Not Available

  • Hemant Makan

    Johannesburg 993800, Gauteng 1085594 1827
    South Africa

    Site Not Available

  • Dr Moosa's Rooms

    Lenasia 983199, Gauteng 1085594 1827
    South Africa

    Site Not Available

  • Botho ke Bontle Health Services

    Pretoria 964137, Gauteng 1085594 0184
    South Africa

    Site Not Available

  • Dr Mahesh Duki Research And Trial Site

    Durban, KwaZulu Natal 4339
    South Africa

    Site Not Available

  • Dr A Amod

    Durban, KwaZulu-Natal 4092
    South Africa

    Site Not Available

  • Dr MB Moosa's Practice

    Durban, KwaZulu-Natal 4092
    South Africa

    Site Not Available

  • Dr A Amod

    Durban 1007311, KwaZulu-Natal 972062 4092
    South Africa

    Site Not Available

  • Dr MB Moosa's Practice

    Durban 1007311, KwaZulu-Natal 972062 4092
    South Africa

    Site Not Available

  • Dr Mahesh Duki Research And Trial Site

    Durban 1007311, KwaZulu-Natal 972062 4339
    South Africa

    Site Not Available

  • Hospital de Basurto

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • ABS La Roca del Vallés

    La Roca Del Vallés, 08430
    Spain

    Site Not Available

  • Hospital Clínico Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Clinico Virgen de la Victoria

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Quirón

    Pozuelo de Alarcón, 28223
    Spain

    Site Not Available

  • Hospital Universitario Quirónsalud Madrid

    Pozuelo de Alarcón, 28223
    Spain

    Site Not Available

  • Hospital Universitario Quirónsalud Madrid

    Pozuelo de Alarcón 3112989, 28223
    Spain

    Site Not Available

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California 90250
    United States

    Site Not Available

  • Scripps Whittier Diabetes Inst

    La Jolla, California 92037
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • Advanced Investigative Medicine, Inc.

    Hawthorne 5355828, California 5332921 90250
    United States

    Site Not Available

  • Scripps Whittier Diabetes Inst

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln 5366375, California 5332921 95648
    United States

    Site Not Available

  • Northeast Research Institute of Florida

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • South Broward Research LLC

    Miramar, Florida 33027
    United States

    Site Not Available

  • Northeast Research Institute of Florida

    Fleming Island 4155594, Florida 4155751 32003
    United States

    Site Not Available

  • South Broward Research LLC

    Miramar 4164601, Florida 4155751 33027
    United States

    Site Not Available

  • Endo Res Solutions Inc

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Endo Res Solutions Inc

    Roswell 4219934, Georgia 4197000 30076
    United States

    Site Not Available

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas 66606-2806
    United States

    Site Not Available

  • Cotton-Oneill Diabetes and End

    Topeka 4280539, Kansas 4273857 66606-2806
    United States

    Site Not Available

  • International Diabetes Center

    Minneapolis, Minnesota 55416
    United States

    Site Not Available

  • International Diabetes Center

    Minneapolis 5037649, Minnesota 5037779 55416
    United States

    Site Not Available

  • Jefferson City Medical Group, PC

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • Jefferson City Medical Group, PC

    Jefferson City 4392388, Missouri 4398678 65109
    United States

    Site Not Available

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska 68198-3020
    United States

    Site Not Available

  • Univ of Nebraska Medical CTR

    Omaha 5074472, Nebraska 5073708 68198-3020
    United States

    Site Not Available

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Palm Research Center Inc-Vegas

    Las Vegas 5506956, Nevada 5509151 89148
    United States

    Site Not Available

  • Southern NH Diabetes and Endo_Nashua

    Nashua, New Hampshire 03060
    United States

    Site Not Available

  • Southern NH Diabetes and Endo_Nashua

    Nashua 5090046, New Hampshire 5090174 03060
    United States

    Site Not Available

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Accellacare Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • PharmQuest Life Sciences LLC

    Greensboro 4469146, North Carolina 4482348 27408
    United States

    Site Not Available

  • Accellacare Wilmington

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Site Not Available

  • Trial Management Associates

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Trial Management Associates

    Myrtle Beach 4588718, South Carolina 4597040 29572
    United States

    Site Not Available

  • Amarillo Medical Specialists

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • PrimeCare Medical Group

    Houston, Texas 77024
    United States

    Site Not Available

  • Victorium Clinical Research

    Houston, Texas 77024
    United States

    Site Not Available

  • Amarillo Medical Specialists

    Amarillo 5516233, Texas 4736286 79106
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Victorium Clinical Research

    Houston 4699066, Texas 4736286 77024
    United States

    Site Not Available

  • Chrysalis Clinical Research

    Saint George, Utah 84790
    United States

    Site Not Available

  • Chrysalis Clinical Research

    St. George 5546220, Utah 5549030 84790
    United States

    Site Not Available

  • Rainier Clin Res Ctr Inc

    Renton, Washington 98057
    United States

    Site Not Available

  • Rainier Clin Res Ctr Inc

    Renton 5808189, Washington 5815135 98057
    United States

    Site Not Available

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