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
NCT ID: NCT06340854
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
429 participants
INTERVENTIONAL
2024-04-19
2025-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin icodec
Participants will receive Insulin icodec subcutaneously once weekly.
Insulin icodec
Insulin Icodec will be administered subcutaneously.
Insulin glargine
Insulin glargine will be administered subcutaneously.
Insulin glargine U100
Participants will receive Insulin glargine subcutaneously once daily.
Insulin icodec
Insulin Icodec will be administered subcutaneously.
Insulin glargine
Insulin glargine will be administered subcutaneously.
Interventions
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Insulin icodec
Insulin Icodec will be administered subcutaneously.
Insulin glargine
Insulin glargine will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
* Chronic heart failure classified as being in New York Heart Association Class IV at screening.
* 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).
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Advanced Investigative Medicine, Inc.
Hawthorne, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Clinical Trials Research
Lincoln, California, United States
Northeast Research Institute of Florida
Fleming Island, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
Cotton-Oneill Diabetes and End
Topeka, Kansas, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Jefferson City Medical Group, PC
Jefferson City, Missouri, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Southern NH Diabetes and Endo_Nashua
Nashua, New Hampshire, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare Wilmington
Wilmington, North Carolina, United States
Trial Management Associates
Myrtle Beach, South Carolina, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Victorium Clinical Research
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
"Medical Center Viva Feniks" Ood
Dobrich, , Bulgaria
MHAT "Knyaginya Klementina" -Sofia EAD
Sofia, , Bulgaria
UMHAT Aleksandrovska
Sofia, , Bulgaria
Medical Institute of Ministry of interior
Sofia, , Bulgaria
Medical centre Clinic Nova
Varna, , Bulgaria
Medical centre Berbatov Beli drin
Yambol, , Bulgaria
InnoDiab Forschung GmbH
Essen, , Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, , Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, , Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, , Germany
Institut für Diabetesforschung Osnabrück
Osnabrück, , Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, , Germany
Lifecare Hospital and Research Centre
Bangalore, Karnataka, India
Belgaum Diabetes Centre
Belagavi, Karnataka, India
Manipal Hospital, Old Airport Road, Bengaluru
Bengaluru, Karnataka, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, India
Chellaram Diabetes Institute
Pune, Maharashtra, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, Tamil Nadu, India
Gandhi Hospital & Medical college
Hyderabad, Telangana, India
Malla Reddy Narayana Multispeciality Hospital
Hyderabad, Telangana, India
Government Institute of Medical Sciences
Noida, Uttar Pradesh, India
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh, , India
Christian Medical College and Hospital
Ludhiana, , India
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
Shinjuku-ku, Tokyo, Tokyo, Japan
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, , Japan
Oyama East Clinic_Internal Medicine
Tochigi, , Japan
Noritake Clinic
Ushiku-shi, Ibaraki, , Japan
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opole Voivodeship, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, , Poland
Trialmed CRS
Piotrkow Trybunalski, Łódź Voivodeship, Poland
Advanced Clinical Research LLC
Bayamón, , Puerto Rico
Manati Ctr For Clin Research
Manatí, , Puerto Rico
Hemant Makan
Johannesburg, Gauteng, South Africa
Dr Moosa's Rooms
Lenasia, Gauteng, South Africa
Botho ke Bontle Health Services
Pretoria, Gauteng, South Africa
Dr A Amod
Durban, KwaZulu-Natal, South Africa
Dr MB Moosa's Practice
Durban, KwaZulu-Natal, South Africa
Dr Mahesh Duki Research And Trial Site
Durban, KwaZulu-Natal, South Africa
Hospital Clinic i Provincial
Barcelona, , Spain
ABS La Roca del Vallés
La Roca Del Vallés, , Spain
Hospital Clinico Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, , Spain
Countries
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Other Identifiers
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U1111-1292-6151
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506084-34
Identifier Type: OTHER
Identifier Source: secondary_id
NN1436-7724
Identifier Type: -
Identifier Source: org_study_id
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