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Weekly insulin shot could replace daily pokes for diabetes

NCT ID NCT06340854

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This study tested a new insulin called icodec that is injected just once a week, compared to the standard daily insulin glargine, in 429 adults with type 2 diabetes. Participants received either the weekly or daily insulin for 6 months. The goal was to see if the weekly shot controls blood sugar as well as the daily one, and to check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
insulin icodec (once-weekly injection)
What this could lead to
If it works, this could offer people with type 2 diabetes a simpler option with just one insulin shot per week instead of daily injections.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. Weekly insulin may not control blood sugar as well as daily insulin for some people, and there is always a risk of low blood sugar or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

412 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes type 2

Contacts and locations

Locations

  • ABS La Roca CAP Vicenç_Endocrino

    La Roca Del Vallés, 08430, Spain

  • Accellacare Wilmington

    Wilmington, North Carolina, 28401, United States

  • Advanced Clinical Research LLC

    Bayamón, 00959, Puerto Rico

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California, 90250, United States

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124, United States

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041, India

  • Belgaum Diabetes Centre

    Belagavi, Karnataka, 590001, India

  • Botho ke Bontle Health Services

    Pretoria, Gauteng, 0184, South Africa

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502, United States

  • Centre for Diabetes

    Johannesburg, Gauteng, 2198, South Africa

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081, Poland

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021, India

  • Christian Medical College and Hospital

    Ludhiana, 141008, India

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas, 66606-2806, United States

  • Diabetes and Thyroid Ctr of FW

    Fort Worth, Texas, 76132, United States

  • Dr A Amod

    Durban, KwaZulu-Natal, 4092, South Africa

  • Dr MB Moosa's Practice

    Durban, KwaZulu-Natal, 4092, South Africa

  • Dr Mahesh Duki Research And Trial Site

    Durban, KwaZulu-Natal, 4339, South Africa

  • Dr Moosa's Rooms

    Lenasia, Gauteng, 1827, South Africa

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076, United States

  • FS Endocrine and diabetes Center

    Saidābād, Telangana, 500059, India

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006, Japan

  • Gandhi Hospital & Medical college

    Hyderabad, Telangana, 500003, India

  • Government Institute of Medical Sciences

    Noida, Uttar Pradesh, 201310, India

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, Maharashtra, 411001, India

  • H. Clinico Univ. Virgen de la Victoria

    Málaga, 29010, Spain

  • H.U. Quirónsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Headlands Research CTR Lincoln

    Lincoln, California, 95648, United States

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034, Japan

  • Hemant Makan

    Johannesburg, Gauteng, 1827, South Africa

  • Hospital Clinic i Provincial

    Barcelona, 08036, Spain

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • InnoDiab Forschung GmbH

    Essen, 45136, Germany

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

    Münster, 48145, Germany

  • Institut für Diabetesforschung Osnabrück

    Osnabrück, 49080, Germany

  • International Diabetes Center

    Minneapolis, Minnesota, 55416, United States

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266, United States

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

    Puducherry, Tamil Nadu, 605006, India

  • Jefferson City Medical Group, PC

    Jefferson City, Missouri, 65109, United States

  • Lifecare Hospital and Research Centre

    Bangalore, Karnataka, 560092, India

  • MC Berbatov EOOD, Beli Drin

    Yambol, 8600, Bulgaria

  • MHAT Knyaginya Klementina - Sofia EAD

    Sofia, 1233, Bulgaria

  • Malla Reddy Narayana Multispeciality Hospital

    Hyderabad, Telangana, 500055, India

  • Manati Ctr For Clin Research

    Manati, 00674, Puerto Rico

  • Manipal Hospital, Old Airport Road, Bengaluru

    Bengaluru, Karnataka, 560017, India

  • Medi-Clinic Bloemfontein

    Bloemfontein, Free State, 9301, South Africa

  • Medical Center Viva Feniks OOD

    Dobrich, 9300, Bulgaria

  • Medical Centre - Clinic Nova EOOD

    Varna, 9000, Bulgaria

  • Medical Institute of Ministry of interior

    Sofia, 1606, Bulgaria

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153, Germany

  • NZOZ Euromedica Sp. z o.o.

    Grudziądz, 86-300, Poland

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435, Poland

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship, 15-879, Poland

  • Noritake Clinic

    Ushiku-shi, Ibaraki, 300-1207, Japan

  • Northeast Research Institute of Florida

    Fleming Island, Florida, 32003, United States

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022, Japan

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148, United States

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507, Poland

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408, United States

  • PlanIt Research, PLLC

    Houston, Texas, 77079, United States

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

    Chandigarh, 160012, India

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758, Germany

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057, United States

  • Rocky Mountain Diab&Osteo Ctr

    Idaho Falls, Idaho, 83404-7596, United States

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037, United States

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012, India

  • South Broward Research LLC

    Miramar, Florida, 33027, United States

  • Southern NH Diabetes and Endo_Nashua

    Nashua, New Hampshire, 03060, United States

  • Swasthya Diabetes Care

    Ahmedabad, Gujarat, 390013, India

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh, 452010, India

  • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

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

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572, United States

  • Trialmed CRS

    Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland

  • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

    Sofia, 1431, Bulgaria

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020, United States

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, Opole Voivodeship, 45-401, Poland

  • Valley Research

    Fresno, California, 93720, United States

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230, United States

  • Velocity Clinical_Valparaiso

    Valparaiso, Indiana, 46383, United States

  • Victorium Clinical Research

    Houston, Texas, 77024, United States

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239, Germany

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