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Weekly shot could replace daily insulin for diabetes

NCT ID NCT06269107

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new once-weekly injection called IcoSema, which combines two diabetes drugs (insulin icodec and semaglutide), against daily insulin glargine in 485 adults with type 2 diabetes whose blood sugar was not well controlled on oral medications. The goal was to see if the weekly shot could lower blood sugar (HbA1c) as well or better than the daily insulin. The trial lasted about 11 months.

What this could mean

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

Active substance
IcoSema (a combination of insulin icodec and semaglutide)
What this could lead to
If successful, this could offer a once-weekly injection option for type 2 diabetes, potentially improving convenience and blood sugar control compared to daily insulin.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The new drug may not prove superior to existing daily insulin, and side effects like nausea or hypoglycemia are possible.

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

485 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 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: * Male or female and age above or equal to 18 years at the time of signing the informed consent. * Diagnosed with T2D greater than or equal to (≥) 180 days before screening. * HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole \[mmol/mol\]) as assessed by central laboratory on the day of screening. * Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes. * Currently treated with 1-3 oral anti diabetic drug (OADs) with stable daily doses ≥ 90 days before screening comprising any of the following anti diabetic drug(s) at effective or maximum tolerated dose. * Metformin * Sulfonylureas * Meglitinides (glinides) * Dipeptidyl peptidase (DPP) 4 inhibitors * Sodium glucose co transporter 2 inhibitors * Alpha glucosidase inhibitors * Thiazolidinediones * Marketed oral combination products only including the products listed above. * Body mass index (BMI) less than or equal to (≤) 40.0 kilogram per square meter (kg/m\^2). Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbaring potential and not using highly effective contraceptive method. * Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids). * Any episodes of diabetic ketoacidosis or treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. * Presence or history of pancreatitis (acute or chronic) within 180 days before screening. * Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. * Chronic heart failure classified as being in New York Heart Association Class IV at screening. * Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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.

Type 2 diabetes

Contacts and locations

Locations

  • "Laiko" General Hospital of Athens

    Athens, 11527, Greece

  • "Thermi" Private Hosital

    Thessaloniki, 57001, Greece

  • 'G. Gennimatas' General Hospital of Athens

    Athens, 115 27, Greece

  • A.O.U. Policlinico Umberto I

    Rome, Lazio, 00161, Italy

  • AMC Community Endocrinology

    Albany, New York, 12203, United States

  • ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia

    L’Aquila, Abbruzzo, 67100, Italy

  • Advanced Clinical Research LLC

    Bayamón, 00959, Puerto Rico

  • Advanced Medical Research

    Maumee, Ohio, 43537, United States

  • Akdeniz University Tip Fakultesi Hastanesi

    Antalya, 07058, Turkey (Türkiye)

  • Akdeniz Üniversitesi Hastanesi- Endokrinoloji

    Antalya, 07058, Turkey (Türkiye)

  • Albuquerque Clin Trials, Inc.

    Albuquerque, New Mexico, 87102, United States

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106, United States

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

    Perugia, 06129, Italy

  • BSES MG hospital

    Mumbai, Maharashtra, 400058, India

  • BYL Nair Hospital and T N Medical College Department of endo

    Mumbai, Maharashtra, 400008, India

  • Başakşehir Çam ve Sakura Şehir Hastanesi

    Istanbul, 34480, Turkey (Türkiye)

  • Beijing Friendship Hospital, Capital Medical University-Endocrinology

    Beijing, Beijing Municipality, 100050, China

  • CHL Hospitals

    Indore, Madhya Pradesh, 452008, India

  • Care Clinic Sp. z o. o.

    Katowice, 40-568, Poland

  • Casa Sollievo della Sofferenza reparto endocrinologia

    San Giovanni Rotondo, FG, 71013, Italy

  • Casa della Salute di Ceccano - Ambulatori Campus Biomedico

    Ceccano (Frosinone), 03023, Italy

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607, United States

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

    Lodz, 90-338, Poland

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021, India

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000, China

  • Clinhouse Centrum Medyczne

    Zabrze, 41-807, Poland

  • Clinical Research Institute of South Africa

    KwaDukuza, KwaZulu-Natal, 4449, South Africa

  • Clinical Research of Cent FL

    Winter Haven, Florida, 33880, United States

  • Clinical Trials Research_Sacramento

    Lincoln, California, 95821, United States

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Cotton-O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606, United States

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 91355, United States

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262, United States

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718, United States

  • Diabetes and Thyroid Ctr of FW

    Fort Worth, Texas, 76132, United States

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006, India

  • Dr Pillay's Rooms

    Durban, KwaZulu-Natal, 4450, South Africa

  • Dr R Dulabh

    Johannesburg, Gauteng, 1812, South Africa

  • East Coast Institute For Research

    Jacksonville, Florida, 32208, United States

  • East West Medical Research Institute_Honolulu

    Honolulu, Hawaii, 96814, United States

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221, United States

  • Endeavor Health

    Skokie, Illinois, 60077, United States

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076, United States

  • Endo and Metab Consultants

    Rockville, Maryland, 20852, United States

  • Epic Medical Research

    Red Oak, Texas, 75154, United States

  • Essential Medical Research LLC

    Tulsa, Oklahoma, 74137, United States

  • Evangelismos Hospital

    Athens, 10676, Greece

  • First Valley Med Grp Lancaster

    Lancaster, California, 93534, United States

  • Flourish Research

    San Antonio, Texas, 78229, United States

  • Fmc Science, Llc

    Lampasas, Texas, 76550, United States

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031, Japan

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132, Poland

  • General Hospital of Kalamata - B Internal Medicine Department

    Kalamata, 24100, Greece

  • Goa Medical College

    Goa, Maharashtra, 403 202, India

  • Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Grazyna Pulka Specjalistyczny Osrodek "All-Med"

    Krakow, 30-033, Poland

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034, Japan

  • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

    Hengshui, Hebei, 053000, China

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong, 516001, China

  • I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani

    Ancona, 60127, Italy

  • IPGME&R and SSKM Hospital

    Kolkata, 700020, India

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • John Muir Physicians Network

    Concord, California, 94520, United States

  • Juntendo University Hospital_Diabetes, endocrinology and metabolism

    Tokyo, 113-8431, Japan

  • Langeberg Clinical Trials

    Cape Town, Western Cape, 7572, South Africa

  • METTA Clinic (a unit of Healious Global Pvt. Ltd.)

    Kolkata, 700039, India

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086, India

  • Medical Concierge Centrum Medyczne

    Warsaw, 02-798, Poland

  • Methodist Phys. Clinic

    Omaha, Nebraska, 68114, United States

  • Mysore Medical College and Research Institute

    Mysore, Karnataka, 570001, India

  • NBR Polska Tomasz Klodawski

    Warsaw, 00-710, Poland

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelski, 20-538, Poland

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435, Poland

  • New Venture Medical Research

    Wadsworth, Ohio, 44281-9236, United States

  • Newtown Clinical Research

    Johannesburg, Gauteng, 2001, South Africa

  • North Texas Endocrine Center

    Dallas, Texas, 75231, United States

  • Northeast Research Institute

    Fleming Island, Florida, 32003, United States

  • Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine

    Hokkaido, 060-0001, Japan

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022, Japan

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, 02-507, Poland

  • Peking University People's Hospital-Endocrinology

    Beijing, Beijing Municipality, 100044, China

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408, United States

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834, United States

  • Polo Ospedaliero di Chiavari

    Chiavari (genova), 16043, Italy

  • Post Graduate Institute of Medical Education & Research

    Chandigarh, 160012, India

  • Quality Research Inc

    San Antonio, Texas, 78209, United States

  • Ramaiah Memorial Hospital

    Bangalore, Karnataka, 560054, India

  • Roodepoort Medicross Clinical Research Centre

    Roodepoort, Gauteng, 1724, South Africa

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004, India

  • SNZOZ Lege Artis

    Bialystok, 15-404, Poland

  • Sai A Health Wellness LLP

    Bangalore, Karnataka, 560080, India

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037, United States

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012, India

  • Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi

    Istanbul, 34371, Turkey (Türkiye)

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 201200, China

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478, United States

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224, United States

  • T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34899, Turkey (Türkiye)

  • TPMG Clinical Research

    Newport News, Virginia, 23606, United States

  • Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye

    Tekirdağ, 59030, Turkey (Türkiye)

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001, China

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503, United States

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011, China

  • Tokuyama clinic_Diabetic internal medicine

    Chiba, 261-0004, Japan

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027, Japan

  • Udyaan Health Care

    Lucknow, Uttar Pradesh, 226002, India

  • Univ Gen Hospital Larisa

    Larissa, 41110, Greece

  • Univ of Alabama_Birmingham

    Birmingham, Alabama, 35233, United States

  • Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii

    Gdansk, 80-214, Poland

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research- Cedar Park

    Austin, Texas, 78759, United States

  • Velocity Nova Sp. z o.o.

    Lublin, 20-362, Poland

  • Velocity Nova Sp. z o.o.

    Staszów, Świętokrzyskie Voivodeship, 28-200, Poland

  • Wade Family Medicine

    Bountiful, Utah, 84010, United States

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji

    Istanbul, 34390, Turkey (Türkiye)

  • Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji

    Istanbul, 34371, Turkey (Türkiye)

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