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Weekly insulin shot could replace daily injections for diabetes

NCT ID NCT04880850

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tested a new insulin called icodec that is injected just once a week, compared to a standard daily insulin (glargine), in 582 adults with type 2 diabetes. Participants also used mealtime insulin as needed. The goal was to see if the weekly insulin controls blood sugar as well as the daily one over 26 weeks. The trial is complete, and results will show whether weekly dosing is a safe and effective option.

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 successful, this could offer people with type 2 diabetes a more convenient once-weekly insulin option instead of daily injections, potentially improving adherence and quality of life.
What could go wrong
This is a completed Phase 3 trial, but results may not show non-inferiority or safety equivalence to daily insulin. Individual responses vary, and weekly dosing may not suit everyone.

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

582 people

The number who actually took part.

Started

May 2021

Finished

Jun 2022

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Male or female aged above or equal to 18 years at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus (T2D) greater than or equal to 180 days prior to the day of screening. * Glycated haemoglobin (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 basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, insulin glulisine) greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening: Metformin / Sulfonylureas / Meglitinides (glinides) / DPP-4 inhibitors / SGLT2 inhibitors / Thiazolidinediones / Alpha-glucosidase inhibitors / Oral combination products (for the allowed individual oral anti-diabetic drugs) / Oral or injectable GLP-1-receptor agonists * Body mass index (BMI) below or equal to 40.0 kg/m\^2. Exclusion Criteria: * Any episodes (as declared by the subject or in the medical records.) 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 mellitus type 2

Contacts and locations

Locations

  • A.O.U. Università Studi della Campania "Luigi Vanvitelli"

    Naples, Campania, 80138, Italy

  • A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura

    Bologna, 40138, Italy

  • AM Diabetes And Endocrinology Center

    Bartlett, Tennessee, 38133, United States

  • AMC Community Endocrinology

    Albany, New York, 12206, United States

  • All India Institute of Medical Sciences

    New Dehli, New Delhi, 110029, India

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106, United States

  • Anaheim Clinical Trials

    Anaheim, California, 92801, United States

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045, Russia

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033, United States

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, Cz, 88100, Italy

  • BSES MG hospital

    Mumbai, Maharashtra, 400058, India

  • Bangalore Clinisearch

    Bangalore, Karnataka, 560043, India

  • Baylr Sctt White Rs Inst, Endo

    Dallas, Texas, 75226, United States

  • Belgaum Diabetes Centre

    Belagavi, Karnataka, 590001, India

  • Bethesda Diabetes Research Center en Bethesda ziekenhuis

    Hoogeveen, 7909 AA, Netherlands

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Helora - Site Warquignies

    Boussu, 7300, Belgium

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502, United States

  • Centro de Investigacion Medica de Occidente S.C.

    Zapopan, Jalisco, 45116, Mexico

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708, United States

  • City Clinical Hospital №52

    Moscow, 123182, Russia

  • City Hospital #5

    Barnaul, 656045, Russia

  • Clinical Emergency Sf. Apostol Andrei Hospital

    Galati, 800578, Romania

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida, 33324, United States

  • Clinical Trials Research_Sacramento_0

    Sacramento, California, 95821, United States

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Brussels, 1200, Belgium

  • Coastal Metabolic Research Center

    Ventura, California, 93003, United States

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605, United States

  • Diabetes Research Center

    Tustin, California, 92780, United States

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006, India

  • Diabetes/Lipid Mgmt & Res Ctr

    Huntington Beach, California, 92648, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • East West Med Res Inst

    Honolulu, Hawaii, 96814, United States

  • Fortis Hospital, Shalimar Bagh, New Delhi

    New Delhi, National Capital Territory of Delhi, 110088, India

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006, Japan

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn, 7334 DZ, Netherlands

  • Grant Medical Foundation

    Pune, Maharashtra, 411001, India

  • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

    Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Hospital Universitario Dr. José Eleuterio González_Monterrey

    Monterrey, Nuevo León, 64460, Mexico

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN, Netherlands

  • Imeldaziekenhuis - Bonheiden - Department of Endocrinology

    Bonheiden, 2820, Belgium

  • Indiana-Armstrong Endocrinology Associates

    Indiana, Pennsylvania, 15701, United States

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucurestii, 020475, Romania

  • Istituto Scientifico San Raffaele

    Milan, MI, 20132, Italy

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216, United States

  • Jefferson City Medical Group, PC

    Jefferson City, Missouri, 65109, United States

  • John Muir Physicians Network

    Concord, California, 94520, United States

  • KSFMU, Inrereginal Clinical Diagnostic center

    Kazan', 420010, Russia

  • Kirov Clinical Hospital #7

    Kirov, 610014, Russia

  • Kurnool Medical Collage

    Kurnool, Andhra Pradesh, 518002, India

  • LLC "Centr Targetnoy Terapii"

    Moscow, 125008, Russia

  • Lifecare Hospital and Research Centre

    Bangalore, Karnataka, 560092, India

  • Limited Law Company "Healthy Family" Medicine Center"

    Novosibirsk, 630099, Russia

  • Limited Liability Company "AriVa-Med"

    Kursk, 305016, Russia

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204, United States

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX, Netherlands

  • Manipal Hospital, Hebbal, Bengaluru

    Bengaluru, Karnataka, 560 024, India

  • Mariodiab Clinic SRL

    Brasov, 500101, Romania

  • MassResearch, LLC

    Waltham, Massachusetts, 02453, United States

  • Maulana Azad Medical College

    Delhi, New Delhi, 110002, India

  • Max Super Speciality Hospital, Saket

    New Delhi, National Capital Territory of Delhi, 110017, India

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM, Netherlands

  • MedStar Diabetes Institute

    Washington D.C., District of Columbia, 20010, United States

  • Medanta - The Medicity Multi-Speciality Hospital, Gurugram

    Gurgaon, Haryana, 122001, India

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401, United States

  • Methodist Physicians Clin

    Omaha, Nebraska, 68114, United States

  • Mountain Diabetes & Endocrine Center

    Asheville, North Carolina, 28803, United States

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113, Japan

  • Noritake Clinic

    Ushiku-shi, Ibaraki, 300-1207, Japan

  • North Texas Endocrine Center

    Dallas, Texas, 75231, United States

  • Northport VA Medical Center_Northport_0

    Northport, New York, 11768, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Oregon Health & Science University_Portland_0

    Portland, Oregon, 97239, United States

  • Osvaldo A. Brusco MD PA

    Corpus Christi, Texas, 78414, United States

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022, Japan

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148, United States

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834, United States

  • Physicians Research Assoc. LLC

    Lawrenceville, Georgia, 30046, United States

  • Prince Aly Khan Hospital

    Mumbai, Maharashtra, 400010, India

  • Prisma Health-Upstate

    Greenville, South Carolina, 29605-4254, United States

  • Protenium Clinical Research_Hurst

    Fort Worth, Texas, 76113, United States

  • Regional clinical cardiology dispensary

    Saratov, 410039, Russia

  • Renai Medicity

    Kochi, Kerala, 682025, India

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD, Netherlands

  • S.C. Medcon S.R.L

    Buzău, 120203, Romania

  • S.C.B. Medical College

    Cuttack, Odisha, 753007, India

  • SPb SBHI City Outpatient clinic #37

    Saint Petersburg, 191119, Russia

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Saltzer Medical Group Research

    Nampa, Idaho, 83686-6011, United States

  • Sasaki Internal Medicine

    Hokkaido, 062-0007, Japan

  • Sc Mediab Srl

    Târgu Mureş, Mureș County, 540142, Romania

  • Shimizu Clinic Fusa

    Saitama, 336-0967, Japan

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224, United States

  • Spitalul Judetean de Urgenta Targoviste

    Targoviste, Dâmbovița County, 130083, Romania

  • St.John's Hospital

    Bangalore, Karnataka, 560034, India

  • Sugimoto Clinic,Internal Medicine

    Kitakyusyu-shi, Fukuoka, 800-0222, Japan

  • Texas Diab & Endo, P.A.

    Austin, Texas, 78731, United States

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749, United States

  • The Jikei University Hospital Dept of Diabetes, Metabolic

    Tokyo, 105-8471, Japan

  • Tumen State Medical University

    Tyumen, Russia, 625023, Russia

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302, United States

  • UZ Leuven - Endocrinology

    Leuven, 3000, Belgium

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650, Belgium

  • Unidad Biomedica Avanzada Monterrey

    Monterrey, Nuevo León, 64460, Mexico

  • Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale

    Roma, 00161, Italy

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • Università degli Studi G. D'Annunzio

    Chieti, 66100, Italy

  • VA NEB - Western IA Health Stm

    Omaha, Nebraska, 68105, United States

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325, United States

  • Valley Research

    Fresno, California, 93720, United States

  • Vanderbilt Diab Obes Clin Tri

    Nashville, Tennessee, 37212, United States

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana, 46383, United States

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230, United States

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421, United States

  • Your Diabetes Endocrine Nutrition Group, Inc.

    Mentor, Ohio, 44060, United States

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