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New weekly insulin shot could simplify diabetes care

NCT ID NCT04770532

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new insulin called icodec that is injected just once a week, compared to a standard daily insulin (degludec), in 526 adults with type 2 diabetes. The goal was to see if the weekly insulin controls blood sugar as well as the daily one over 26 weeks. Participants wore a continuous glucose monitor for part of the study and had regular blood tests.

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

526 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 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 T2D greater than or 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 units/mL, or insulin glargine 300 units/mL): 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

  • "University Clinic" of Dnipro State Medical University - Endocrinology department

    Dnipro, 49038, Ukraine

  • AMC Community Endocrinology

    Albany, New York, 12203, United States

  • ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva

    Rousse, 7002, Bulgaria

  • Accellacare

    Wilmington, North Carolina, 28401, United States

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106, United States

  • American Clinical Trials

    Buena Park, California, 90620, United States

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Baylr Sctt White Rs Inst, Endo

    Dallas, Texas, 75226, United States

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115-5804, United States

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502, United States

  • Cedars-Sinai Medical Group

    Encino, California, 91436, United States

  • Centre for Diabetes

    Johannesburg, Gauteng, 2198, South Africa

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-338, Poland

  • Chris Hani Baragwanath Hospital

    Johannesburg, Gauteng, 2013, South Africa

  • Clinical Trials Research_Sacramento

    Lincoln, California, 95648, United States

  • Department of Medical Service and Rehabilitation of "ARTEM" - day hospital department

    Kyiv, 04053, Ukraine

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262, United States

  • Diabetes and Thyroid Ctr of FW

    Fort Worth, Texas, 76132, United States

  • Diabetes/Lipid Mgmt & Res Ctr

    Huntington Beach, California, 92648, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Dr A Amod

    Durban, KwaZulu-Natal, 4092, South Africa

  • Endo And Metab Cons

    Rockville, Maryland, 20852, United States

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076, United States

  • Four Rivers Clinical Research Inc

    Paducah, Kentucky, 42001, United States

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006, Japan

  • Greenacres Hospital

    Port Elizabeth, Eastern Cape, 6045, South Africa

  • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

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

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034, Japan

  • Hemant Makan

    Johannesburg, Gauteng, 1827, South Africa

  • Hillcrest Family Health Center

    Waco, Texas, 76708, United States

  • Hospital Luz Arrabida, S.A.

    Vila Nova de Gaia, 4400-346, Portugal

  • Ileana J Tandron APMC

    Slidell, Louisiana, 70461-4231, United States

  • InnoDiab Forschung GmbH

    Essen, 45136, Germany

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

    Münster, 48145, Germany

  • Juntendo University Hospital_Tokyo

    Tokyo, 113-8431, Japan

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology

    Kyiv, 04114, Ukraine

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • MHAT Med Line Clinic

    Plovdiv, 4000, Bulgaria

  • MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases

    Sofia, 1606, Bulgaria

  • MZM Praxis Drs. Erlinger

    Stuttgart, 70378, Germany

  • MassResearch, LLC

    Waltham, Massachusetts, 02453, United States

  • Medi-Clinic Bloemfontein

    Bloemfontein, Free State, 9301, South Africa

  • Medical center Medi City 21 OOD

    Kyustendil, 2500, Bulgaria

  • Milek, Hohenmölsen

    Hohenmölsen, 06679, Germany

  • Mountain Diabetes & Endocrine Center

    Asheville, North Carolina, 28803, United States

  • NZOZ "DiabMed" Poradnia Diabetologiczna

    Poznan, 60-821, Poland

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113, Japan

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119, United States

  • Noritake Clinic

    Ushiku-shi, Ibaraki, 300-1207, Japan

  • Northport VA Med Ctr Northport

    Northport, New York, 11768, United States

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 139-827, South Korea

  • OCIPSOMCEMD ENDO MED-CONSULT - Dr. Nikolay Botushanov

    Plovdiv, 4002, Bulgaria

  • Osvaldo A. Brusco MD PA

    Corpus Christi, Texas, 78414, United States

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022, Japan

  • Palm Research Center Inc.

    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

  • Praxis Dr. med. Wenzl-Bauer

    Rehlingen-Siersburg, 66780, Germany

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037, United States

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478, United States

  • South Broward Research LLC

    Miramar, Florida, 33027, United States

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Ternopil Central District Hospital - Outpatient department

    Ternopil, 46001, Ukraine

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • Thyroid, Endocrinology, and Diabetes, PA

    Dallas, Texas, 75208, United States

  • Tokuyama clinic_Diabetic internal medicine

    Chiba, 261-0004, Japan

  • UMHAT Sofiamed EAD

    Sofia, 1797, Bulgaria

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302, United States

  • Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta

    Almada, 2805-267, Portugal

  • Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz

    Lisbon, 1349-019, Portugal

  • Unidade Local De Saude De Matosinhos E.P.E.

    Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal

  • Unidade Local de Saude de Sao Joao E.P.E

    Porto, 4200-319, Portugal

  • Unidade Local de Saúde de Coimbra, E.P.E.

    Coimbra, 3000-561, Portugal

  • Unidade Local de Saúde de Santo António, E.P.E

    Porto, 4099-001, Portugal

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325, United States

  • Valley Research

    Fresno, California, 93720, United States

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana, 46383, United States

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230, United States

  • VvP Kliniken gGmbH Marienhospital Stuttgart - Innere Medizin I

    Stuttgart, 70199, Germany

  • Wendisch/Dahl Hamburg (DZHW)

    Hamburg, 22607, Germany

  • Yuri Ono Clinic

    Sapporo-shi, Hokkaido, 060-0001, Japan

  • Zentrum für klinische Studien Alexander Segner

    Saint Ingbert-Oberwürzbach, 66386, Germany

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