NCT06340854CompletedPhase 3
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
A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 412 (actual)
- First submitted
- 26 Mar 2024
- Start date
- 19 Apr 2024
- Primary completion date
- 8 May 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT06340854
- EU CT number
- 2023-506084-34-00
- EudraCT number
- 2023-506084-34
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 412
- From 19 Apr 2024 to the primary completion date, 8 May 2025
- 82 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.
Other illness
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
Lab values
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
Who the study is looking for
- 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 by central laboratory analysis.
- Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the 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, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products.
- Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (82)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Viva Phoenix OOD Coordinator of this site? Confirm its status | Dobrich | Bulgaria | Completed |
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Medical Institute Ministry Of Interior Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Medcenter Nova Clinic Ltd. Coordinator of this site? Confirm its status | Varna | Bulgaria | Completed |
| Medical Center Berbatov Ltd. Coordinator of this site? Confirm its status | Yambol | Bulgaria | Completed |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Institut fuer Diabetesforschung Muenster GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| Schwerpunktpraxis für Diabetes und Ernährungsmedizin Coordinator of this site? Confirm its status | Münster | Germany | Completed |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Completed |
| Institut für Diabetesforschung Osnabrück Coordinator of this site? Confirm its status | Osnabrück | Germany | Completed |
| Zentrum für klinische Forschung Allgäu-Oberschwaben Coordinator of this site? Confirm its status | Wangen | Germany | Completed |
| Projectes Sanitaris I Socials S.A. Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| Swasthya Diabetes Care Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Lifecare Hospital and Research Centre Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Belgaum Diabetes Centre Coordinator of this site? Confirm its status | Belagavi | India | Unknown status |
| Manipal Hospital, Old Airport Road, Bengaluru Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Malla Reddy Narayana Multispeciality Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Gandhi Hospital & Medical college Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| TOTALL Diabetes Hormone Institute Coordinator of this site? Confirm its status | Indore | India | Unknown status |
| Amrita Institute of Medical Sciences & Research Centre Coordinator of this site? Confirm its status | Kochi | India | Unknown status |
| Christian Medical College and Hospital Coordinator of this site? Confirm its status | Ludhiana | India | Unknown status |
| Seth GS Medical College & KEM Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Government Institute of Medical Sciences Coordinator of this site? Confirm its status | Noida | India | Unknown status |
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
| Grant Medical Foundation Ruby Hall Clinic Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Chellaram Diabetes Institute Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| FS Endocrine and diabetes Center Coordinator of this site? Confirm its status | Saidābād | India | Unknown status |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine Coordinator of this site? Confirm its status | Fukuoka-shi, Fukuoka | Japan | Unknown status |
| Heiwadai Hospital_Internal Medicine Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology Coordinator of this site? Confirm its status | Shinjuku-ku, Tokyo | Japan | Unknown status |
| Oyama East Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tochigi | Japan | Unknown status |
| Noritake Clinic Coordinator of this site? Confirm its status | Ushiku-shi, Ibaraki | Japan | Unknown status |
| Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Niepubliczny Zakład Opieki Zdrowotnej Vita-Diabetica Małgorzata Buraczyk Coordinator of this site? Confirm its status | Białystok | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Opolu Coordinator of this site? Confirm its status | Opole | Poland | Completed |
| Trialmed Sp. z o. o. Coordinator of this site? Confirm its status | Piotrkow Trybunalski | Poland | Completed |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Advanced Clinical Research, LLC Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| Manati Ctr For Clin Research Coordinator of this site? Confirm its status | Manati | Puerto Rico | Unknown status |
| Amarillo Medical Specialists Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Velocity Clinical Res-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Northeast Research Institute of Florida Coordinator of this site? Confirm its status | Fleming Island | United States | Unknown status |
| Diabetes and Thyroid Ctr of FW Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Valley Research Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| PharmQuest Life Sciences LLC Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Advanced Investigative Medicine, Inc. Coordinator of this site? Confirm its status | Hawthorne | United States | Unknown status |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Victorium Clinical Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Rocky Mountain Diab&Osteo Ctr Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Jefferson City Medical Group PC Coordinator of this site? Confirm its status | Jefferson City | United States | Unknown status |
| Scripps Whittier Diabetes Inst Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Palm Research Center Inc-Vegas Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Headlands Research CTR Lincoln Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| International Diabetes Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| South Broward Research LLC Coordinator of this site? Confirm its status | Miramar | United States | Unknown status |
| Trial Management Associates Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Southern NH Diabetes and Endo_Nashua Coordinator of this site? Confirm its status | Nashua | United States | Unknown status |
| Capital Clin Res Ctr,LLC Coordinator of this site? Confirm its status | Olympia | United States | Unknown status |
| Univ of Nebraska Medical CTR Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Rainier Clin Res Ctr Inc Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Endo Res Solutions Inc Coordinator of this site? Confirm its status | Roswell | United States | Unknown status |
| Chrysalis Clinical Research Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Cotton-Oneill Diabetes and End Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Velocity Clinical_Valparaiso Coordinator of this site? Confirm its status | Valparaiso | United States | Unknown status |
| Iowa Diab & Endo Res Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Accellacare - Wilmington Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Medi-Clinic Bloemfontein Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Dr A Amod Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Dr MB Moosa's Practice Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Dr Mahesh Duki Research And Trial Site Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Centre for Diabetes Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Hemant Makan Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Dr Moosa's Rooms Coordinator of this site? Confirm its status | Lenasia | South Africa | Unknown status |
| Botho ke Bontle Health Services Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.