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NCT06340854

PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2024-04-19

Completion Date

2025-06-13

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Diabetes, Type 2

Interventions

DRUG

Insulin icodec

Insulin Icodec will be administered subcutaneously.

DRUG

Insulin glargine

Insulin glargine will be administered subcutaneously.

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 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: * 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. * 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.

Locations (83)

Valley Research

Fresno, California, United States

Advanced Investigative Medicine, Inc.

Hawthorne, California, United States

Scripps Whittier Diabetes Inst

La Jolla, California, United States

Headlands Research CTR Lincoln

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

Rocky Mountain Diab&Osteo Ctr

Idaho Falls, Idaho, United States

Velocity Clinical_Valparaiso

Valparaiso, Indiana, United States

Iowa Diab & Endo Res Center

West Des Moines, Iowa, 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

Diabetes and Thyroid Ctr of FW

Fort Worth, 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

Capital Clin Res Ctr,LLC

Olympia, Washington, 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 EAD, Clinic of Endocrinology and Metabolic Diseases

Sofia, Bulgaria

Medical Institute of Ministry of interior

Sofia, Bulgaria

Medical Centre - Clinic Nova EOOD

Varna, Bulgaria

MC Berbatov EOOD, 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

Swasthya Diabetes Care

Ahmedabad, Gujarat, India

Lifecare Hospital and Research Centre

Bangalore, Karnataka, India

Belgaum Diabetes Centre

Belagavi, Karnataka, India

Manipal Hospital, Old Airport Road, Bengaluru

Bengaluru, Karnataka, India

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 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

FS Endocrine and diabetes Center

Saidābād, 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

NZOZ Euromedica Sp. z o.o.

Grudziądz, 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

Manati, Puerto Rico

Medi-Clinic Bloemfontein

Bloemfontein, Free State, South Africa

Hemant Makan

Johannesburg, Gauteng, South Africa

Centre for Diabetes

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 de Basurto

Bilbao, Vizcaya, Spain

Hospital Clinic i Provincial

Barcelona, Spain

ABS La Roca CAP Vicenç_Endocrino

La Roca Del Vallés, Spain

H. Clinico Univ. Virgen de la Victoria

Málaga, Spain

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (83)