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Weekly insulin shot plus skin sensor could simplify diabetes care

NCT ID NCT05823948

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 approach for people with type 2 diabetes: a once-weekly insulin injection (insulin icodec) combined with a flash glucose monitor, a small sensor worn on the arm that tracks blood sugar continuously. The goal was to see if this combination helps control blood sugar levels over 26 weeks. The study involved 51 adults with type 2 diabetes who had never used insulin before. Participants injected insulin once a week and scanned the sensor four times daily using a study phone.

What this could mean

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

Active substance
insulin icodec (once-weekly insulin injection)
What this could lead to
If successful, this could make managing type 2 diabetes easier with a once-weekly insulin shot and a simple sensor to track blood sugar.
What could go wrong
This is a small, completed Phase 3 trial with only 51 participants. Results may not apply to everyone, and insulin can cause low blood sugar or other side effects.

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

51 people

The number who actually took part.

Started

Apr 2023

Finished

Apr 2024

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: * 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

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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

  • AM Diabetes And Endocrinology

    Bartlett, Tennessee, 38133, United States

  • Accellacare_NC

    Wilmington, North Carolina, 28401, United States

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124, United States

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Clinical Trials Research_Sacramento_0

    Sacramento, California, 95821, United States

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229, United States

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262, United States

  • Diabetes & Endocrinology Asso

    Canton, Ohio, 44718, United States

  • East West Med Res Inst

    Honolulu, Hawaii, 96814, United States

  • Florida Inst For Clin Res LLC

    Orlando, Florida, 32825, United States

  • Fmc Science, Llc

    Lampasas, Texas, 76550, United States

  • International Diabetes Center

    Minneapolis, Minnesota, 55416, United States

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401, United States

  • Mills-Peninsula Hlth Services

    San Mateo, California, 94401, United States

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas, 78233, United States

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620, United States

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148, United States

  • San Diego Family Care

    San Diego, California, 92111, United States

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302, United States

  • Velocity Clin Res, Dallas

    Dallas, Texas, 75230, United States

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