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Diabetes, Type 2Phase 3NCT06340854

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

A Phase 3 study testing Insulin icodec and Insulin glargine in people with Diabetes, Type 2, run by Novo Nordisk A/S at 83 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Type 2
What is being tested?
Insulin icodec and Insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
83 sitesin 9 countries
Study dates
19 Apr 2024to 13 Jun 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

83 sites in 9 countries.

83 sites in 9 countries

United States27 sites

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • Northeast Research Institute of Florida

    Fleming Island, Florida, 32003

  • Diabetes and Thyroid Ctr of FW

    Fort Worth, Texas, 76132

  • Valley Research

    Fresno, California, 93720

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California, 90250

  • Victorium Clinical Research

    Houston, Texas, 77024

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Rocky Mountain Diab&Osteo Ctr

    Idaho Falls, Idaho, 83404-7596

  • Jefferson City Medical Group, PC

    Jefferson City, Missouri, 65109

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148

  • Headlands Research CTR Lincoln

    Lincoln, California, 95648

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • Southern NH Diabetes and Endo_Nashua

    Nashua, New Hampshire, 03060

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas, 66606-2806

  • Velocity Clinical_Valparaiso

    Valparaiso, Indiana, 46383

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266

  • Accellacare Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

India16 sites

  • Swasthya Diabetes Care

    Ahmedabad, Gujarat, 390013

  • Lifecare Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • Belgaum Diabetes Centre

    Belagavi, Karnataka, 590001

  • Manipal Hospital, Old Airport Road, Bengaluru

    Bengaluru, Karnataka, 560017

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

    Chandigarh, 160012

  • Gandhi Hospital & Medical college

    Hyderabad, Telangana, 500003

  • Malla Reddy Narayana Multispeciality Hospital

    Hyderabad, Telangana, 500055

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh, 452010

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • Christian Medical College and Hospital

    Ludhiana, 141008

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012

  • Government Institute of Medical Sciences

    Noida, Uttar Pradesh, 201310

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

    Puducherry, Tamil Nadu, 605006

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021

  • FS Endocrine and diabetes Center

    Saidābād, Telangana, 500059

Other trials in India

Poland8 sites

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship, 15-879

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338

  • NZOZ Euromedica Sp. z o.o.

    Grudziądz, 86-300

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, Opole Voivodeship, 45-401

  • Trialmed CRS

    Piotrkow Trybunalski, Łódź Voivodeship, 97-300

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507

Other trials in Poland

South Africa8 sites

  • Medi-Clinic Bloemfontein

    Bloemfontein, Free State, 9301

  • Dr A Amod

    Durban, KwaZulu-Natal, 4092

  • Dr MB Moosa's Practice

    Durban, KwaZulu-Natal, 4092

  • Dr Mahesh Duki Research And Trial Site

    Durban, KwaZulu-Natal, 4339

  • Hemant Makan

    Johannesburg, Gauteng, 1827

  • Centre for Diabetes

    Johannesburg, Gauteng, 2198

  • Dr Moosa's Rooms

    Lenasia, Gauteng, 1827

  • Botho ke Bontle Health Services

    Pretoria, Gauteng, 0184

Other trials in South Africa

Bulgaria6 sites

  • Medical Center Viva Feniks OOD

    Dobrich, 9300

  • MHAT Knyaginya Klementina - Sofia EAD

    Sofia, 1233

  • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

    Sofia, 1431

  • Medical Institute of Ministry of interior

    Sofia, 1606

  • Medical Centre - Clinic Nova EOOD

    Varna, 9000

  • MC Berbatov EOOD, Beli Drin

    Yambol, 8600

Other trials in Bulgaria

Germany6 sites

  • InnoDiab Forschung GmbH

    Essen, 45136

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

    Münster, 48145

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758

  • Institut für Diabetesforschung Osnabrück

    Osnabrück, 49080

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239

Other trials in Germany

Japan5 sites

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034

  • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

    Shinjuku-ku, Tokyo, Tokyo, 160-0023

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022

  • Noritake Clinic

    Ushiku-shi, Ibaraki, 300-1207

Other trials in Japan

Spain5 sites

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • ABS La Roca CAP Vicenç_Endocrino

    La Roca Del Vallés, 08430

  • H. Clinico Univ. Virgen de la Victoria

    Málaga, 29010

  • H.U. Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

Puerto Rico2 sites

  • Advanced Clinical Research LLC

    Bayamón, 00959

  • Manati Ctr For Clin Research

    Manati, 00674

Other trials in Puerto Rico

About this study

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

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.

Being tested
Insulin icodec, Insulin glargine
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin icodecDrug

    Insulin Icodec will be administered subcutaneously.

  • Insulin glargineDrug

    Insulin glargine will be administered subcutaneously.

Study groups in NCT06340854
Study groupRoleWhat they receive
Insulin icodecExperimentalParticipants will receive Insulin icodec subcutaneously once weekly.
Receives: Drug: Insulin icodec; Drug: Insulin glargine
Insulin glargine U100Active comparatorParticipants will receive Insulin glargine subcutaneously once daily.
Receives: Drug: Insulin icodec; Drug: Insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated Haemoglobin (HbA1c)

    Change in HbA1c from week 0 to week 26 in percentage point is presented.

    Measured: Week 0, Week 26

Secondary outcomes (9)

  1. Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))

    Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements.

    Measured: week -4-0, week 22-26

  2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction

    Change in DTSQs total treatment satisfaction from week 0 to week 26 is presented. DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contribute to 1 global score. Total Treatment Satisfaction score range is 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.

    Measured: week 0 to week 26

  3. Number of Severe Hypoglycaemic Episodes (Level 3)

    Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.

    Measured: From baseline (week 0) to week 31

  4. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)

    Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 31 is presented.

    Measured: From baseline (week 0) to week 31

  5. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

    Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.

    Measured: From baseline (week 0) to week 31

  6. Time Spent < 3.0 mmol/L (54 mg/dL)

    Time spent < 3.0 mmol/L (54 mg/dL) during week 22 - 26 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below 3.0 mmol/L (54 mg/dL), divided by the total number of recorded measurements.

    Measured: Week 22-26

  7. Change in Time Spent > 10.0 mmol/L (180 mg/dL)

    Change in time spent > 10.0 mmol/L 180 mg/dL from week -4 - 0 to week 22-26 is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above 10.0 mmol/L (180 mg/dL) divided by the total number of recorded measurements.

    Measured: Week -4-0, Week 22-26

  8. Mean Weekly Insulin Dose

    Mean weekly insulin dose from week 24 to week 26 is presented.

    Measured: From week 24 to week 26

  9. Change in Body Weight

    Change in body weight from baseline (week 0) to (week 26) is presented.

    Measured: Week 0, Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start19 Apr 2024
  3. Primary completion8 May 2025
  4. Study completion13 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06340854
Sponsor's protocol ID
NN1436-7724
Other IDs
U1111-1292-6151, 2023-506084-34, 2023
Status last verified
Aug 2026
First submitted
26 Mar 2024
Last updated
11 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Publications

  • Rosenstock J, Mathieu C, Feinberg JB, Rao P, Scavenius C, Cheng AYY. Simplified Switching to Once-Weekly Insulin Icodec Without an Initial One-Time Additional Dose Versus Once-Daily Insulin Glargine U100 in Basal Insulin-Treated Type 2 Diabetes (ONWARDS 10): A Randomised Controlled Trial. Diabetes Obes Metab. 2026 Sep;28(9):7791-7801. doi: 10.1111/dom.70813. Epub 2026 May 21.

    PubMed 42168822

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin icodec and Insulin glargine in people with Diabetes, Type 2, run by Novo Nordisk A/S at 83 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, India, Poland, South Africa, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) (time frame: Week 0, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06340854, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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