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) (ONWARDS 9)

April 9, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palm Springs, California, United States, 92262
        • Desert Oasis Hlthcr Med Group
      • Sacramento, California, United States, 95821
        • Clinical Trials Research_Sacramento_0
      • San Diego, California, United States, 92111
        • San Diego Family Care
      • San Mateo, California, United States, 94401
        • Mills-Peninsula Hlth Services
    • Florida
      • Orlando, Florida, United States, 32825
        • Florida Inst For Clin Res LLC
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute Inc
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Med Res Inst
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Hlth Ctr, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc-Vegas
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare_NC
    • Ohio
      • Canton, Ohio, United States, 44718
        • Diabetes & Endocrinology Asso
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes And Endocrinology
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Medical Specialists
      • Dallas, Texas, United States, 75390-9302
        • UT Southwestern Med Cntr
      • Dallas, Texas, United States, 75230
        • Velocity Clin Res, Dallas
      • Lampasas, Texas, United States, 76550
        • Fmc Science, Llc
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas Inc
      • San Antonio, Texas, United States, 78233
        • Northeast Clinical Research of San Antonio
    • Utah
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Any metformin formulations >= 1500 milligrams (mg) or maximum tolerated or effective dose or
    2. Any metformin combination formulations >=1500 mg or maximum tolerated or effective dose or
    3. 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin Icodec
Participants will receive 70 Units (U) insulin icodec subcutaneously once-weekly for 26 weeks.
Drug: Insulin Icodec
Participants will receive insulin icodec once-weekly subcutaneously into the thigh, upper arm or abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Baseline (week 0), week 26
Change in HbA1c from week 0 to week 26 is presented in percentage-point.
Baseline (week 0), week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2023

Primary Completion (Actual)

March 6, 2024

Study Completion (Actual)

April 11, 2024

Study Registration Dates

First Submitted

April 9, 2023

First Submitted That Met QC Criteria

April 9, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-4909
  • U1111-1271-9296 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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