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Diabetes Mellitus, Type 2Phase 3ONWARDS 9NCT05823948

A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)

A Phase 3 study testing Insulin Icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 20 sites in United States.

Completed

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

Official record
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Trial summary

This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin Icodec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
20 sitesUnited States
Study dates
11 Apr 2023to 11 Apr 2024
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

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
  • Age above or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes (T2D) greater than or equal to (>=) 180 days before screening
  • HbA1c from 7.0%-11.0% (53.0-96.7 millimoles per mole [mmol/mol]) both inclusive at screening confirmed by central laboratory analysis
  • Insulin-naïve. However, short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes
  • Stable daily dose(s) >=90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
Show all 11Show fewer
  • Any metformin formulations >= 1500 milligrams (mg) or maximum tolerated or effective dose or
  • Any metformin combination formulations >=1500 mg or maximum tolerated or effective dose or
  • Other antidiabetic Drugs including combination products (>=half of the maximum approved dose according to local label or maximum tolerated or effective dose) of the classes specified below: Sulfonylureas, Meglitinides (glinides), Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors, Thiazolidinedione, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs, Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists
  • Intensification with basal insulin is indicated to achieve fasting glycaemic target (4.4-7.2 millimoles per liter [mmol/L]; 80-130 milligrams per deciliter [mg/dL]) at the discretion of the treating investigator
  • Body mass index (BMI) less than or equal to (<=) 40.0 kilograms per meter square (kg/m^2)

Who cannot join

  • Unwilling or unable to avoid concomitant medication e.g., ascorbic acid (vitamin C) that can influence the flash glucose monitoring (FGM) sensor throughout the study and contraindications e.g., implanted medical devices such as pacemakers
  • Any episodes of diabetic ketoacidosis within 90 days before screening as declared by the participant or in the medical records
  • Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before the day of screening and between screening and initiation visits
  • Chronic heart failure classified as being in New York Heart Association (NYHA) 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 90 days before the day of screening or in the period between screening and initiation visits. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

  • AM Diabetes And Endocrinology

    Bartlett, Tennessee, 38133

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • Diabetes & Endocrinology Asso

    Canton, Ohio, 44718

  • Velocity Clin Res, Dallas

    Dallas, Texas, 75230

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • Fmc Science, Llc

    Lampasas, Texas, 76550

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Florida Inst For Clin Res LLC

    Orlando, Florida, 32825

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262

  • Clinical Trials Research_Sacramento_0

    Sacramento, California, 95821

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas, 78233

  • San Diego Family Care

    San Diego, California, 92111

  • Mills-Peninsula Hlth Services

    San Mateo, California, 94401

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401

  • Accellacare_NC

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes

This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Participants will get insulin icodec that they have to inject once a week on the same day of the week. The insulin will be injected with a needle in a skin fold in the thigh, upper arm, or stomach. The study will last for about 8 months. Participants will have to wear a flash glucose monitor throughout the study. This is a sensor that fits on arm. Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data. Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Being tested
Insulin Icodec
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

    Participants will receive insulin icodec once-weekly subcutaneously into the thigh, upper arm or abdomen.

Study groups in NCT05823948
Study groupRoleWhat they receive
Insulin IcodecExperimentalParticipants will receive 70 Units (U) insulin icodec subcutaneously once-weekly for 26 weeks.
Receives: Drug: Insulin Icodec

What is being measured

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

  1. Change in Glycosylated Haemoglobin (HbA1c)

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

    Measured: Baseline (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 posted21 Apr 2023
  2. Study start11 Apr 2023
  3. Primary completion6 Mar 2024
  4. Study completion11 Apr 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05823948
Sponsor's protocol ID
NN1436-4909
Other IDs
U1111-1271-9296
Acronym
ONWARDS 9
Status last verified
Apr 2026
First submitted
9 Apr 2023
Last updated
30 Apr 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

  • Bergenstal RM, Asbjornsdottir B, Johanning Bari T, Hulkund S, Winhofer Y, Wysham C. Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial. Diabetes Technol Ther. 2025 Jul;27(7):527-536. doi: 10.1089/dia.2025.0050. Epub 2025 Mar 5.

    PubMed 40040516

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 20 sites in United States.

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 11 inclusion and 6 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. 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 30 Apr 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 Glycosylated Haemoglobin (HbA1c) (time frame: Baseline (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 NCT05823948, 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 30 Apr 2026.

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ONWARDS 9 Clinical Trial NCT05823948 | AzTrials