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

April 3, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

429

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

  • Bulgaria
      • Dobrich, Bulgaria, 9300
        • Medical Center Viva Feniks OOD
      • Sofia, Bulgaria, 1606
        • Medical Institute of Ministry of interior
      • Sofia, Bulgaria, 1233
        • MHAT Knyaginya Klementina - Sofia EAD
      • Sofia, Bulgaria, 1431
        • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
      • Varna, Bulgaria, 9000
        • Medical Centre - Clinic Nova EOOD
      • Yambol, Bulgaria, 8600
        • MC Berbatov EOOD, Beli Drin
  • Germany
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Münster, Germany, 48153
        • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
      • Oldenburg in Holstein, Germany, 23758
        • RED-Institut für medizinische Forschung und Fortbildung GmbH
      • Osnabrück, Germany, 49080
        • Institut für Diabetesforschung Osnabrück
      • Wangen, Germany, 88239
        • Zentrum für klinische Studien Allgäu Oberschwaben
  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
      • Ludhiana, India, 141008
        • Christian Medical College and Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Lifecare Hospital and Research Centre
      • Belagavi, Karnataka, India, 590001
        • Belgaum Diabetes Centre
      • Bengaluru, Karnataka, India, 560017
        • Manipal Hospital, Old Airport Road, Bengaluru
    • Kerala
      • Kochi, Kerala, India, 682041
        • Amrita Institute Of Medical Sciences & Research Centre
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Seth GS Medical College & KEM Hospital
      • Pune, Maharashtra, India, 411001
        • Grant Medical foundation Ruby Hall Clinic
      • Pune, Maharashtra, India, 411021
        • Chellaram Diabetes Institute
    • Tamil Nadu
      • Puducherry, Tamil Nadu, India, 605006
        • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
    • Telangana
      • Hyderabad, Telangana, India, 500055
        • Malla Reddy Narayana Multispeciality Hospital
      • Hyderabad, Telangana, India, 500003
        • Gandhi Hospital & Medical college
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India, 201310
        • Government Institute of Medical Sciences
  • Japan
      • Fukuoka-shi, Fukuoka, Japan, 819-0006
        • Futata Tetsuhiro Clinic Meinohama_Internal medicine
      • Tochigi, Japan, 323-0022
        • Oyama East Clinic_Internal Medicine
      • Ushiku-shi, Ibaraki, Japan, 300-1207
        • Noritake Clinic
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 880-0034
        • Heiwadai Hospital_Internal Medicine
    • Tokyo
      • Shinjuku-ku, Tokyo, Tokyo, Japan, 160-0023
        • Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
  • Poland
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Warsaw, Poland, 02-507
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-401
        • Uniwersytecki Szpital Kliniczny w Opolu
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-879
        • NZOZ Vita-Diabetica Malgorzata Buraczyk
      • Bialystok, Podlaskie Voivodeship, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
    • Łódź Voivodeship
      • Piotrkow Trybunalski, Łódź Voivodeship, Poland, 97-300
        • Trialmed CRS
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Advanced Clinical Research LLC
      • Manatí, Puerto Rico, 00674
        • Manati Ctr For Clin Research
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1827
        • Hemant Makan
      • Lenasia, Gauteng, South Africa, 1827
        • Dr Moosa's Rooms
      • Pretoria, Gauteng, South Africa, 0184
        • Botho ke Bontle Health Services
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Dr A Amod
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Dr MB Moosa's Practice
      • Durban, KwaZulu-Natal, South Africa, 4339
        • Dr Mahesh Duki Research And Trial Site
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • La Roca Del Vallés, Spain, 08430
        • ABS La Roca del Vallés_Endocrinología
      • Málaga, Spain, 29010
        • H. Clinico Univ. Virgen de la Victoria
      • Pozuelo de Alarcón, Spain, 28223
        • H.U. Quirónsalud Madrid
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
  • United States
    • California
      • Hawthorne, California, United States, 90250
        • Advanced Investigative Medicine, Inc.
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute of Florida
      • Miramar, Florida, United States, 33027
        • South Broward Research LLC
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endo Res Solutions Inc
    • Kansas
      • Topeka, Kansas, United States, 66606-2806
        • Cotton-Oneill Diabetes and End
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group, PC
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3020
        • Univ of Nebraska Medical CTR
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc-Vegas
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Southern NH Diabetes and Endo_Nashua
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences LLC
      • Wilmington, North Carolina, United States, 28401
        • Accellacare Wilmington
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Trial Management Associates
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Medical Specialists
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Houston, Texas, United States, 77024
        • Victorium Clinical Research
      • Houston, Texas, United States, 77079
        • PlanIt Research, PLLC
    • Utah
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical Research
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clin Res Ctr Inc

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:

  • 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).

Exclusion Criteria:

  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin icodec
Participants will receive Insulin icodec subcutaneously once weekly.
Drug: Insulin glargine
Insulin glargine will be administered subcutaneously.
Drug: Insulin icodec
Insulin Icodec will be administered subcutaneously.
Active Comparator: Insulin glargine U100
Participants will receive Insulin glargine subcutaneously once daily.
Drug: Insulin glargine
Insulin glargine will be administered subcutaneously.
Drug: Insulin icodec
Insulin Icodec will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated hemoglobin (HbA1c)
Time Frame: From baseline (week 0) to week 26
Percentage point (%-point).
From baseline (week 0) to week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL))
Time Frame: From baseline (week -4 to 0) to week 22-26
Percentage (%) of time.
From baseline (week -4 to 0) to week 22-26
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction
Time Frame: From baseline (week 0) to week 26
DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contributes to 1 global score. Higher scores on the global score indicate greater satisfaction with treatment. Global score ranges 0- 36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.
From baseline (week 0) to week 26
Number of severe hypoglycaemic episodes (level 3)
Time Frame: From baseline (week 0) to week 31
Number of episodes.
From baseline (week 0) to week 31
Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter)
Time Frame: From baseline (week 0) to week 31
Number of episodes.
From baseline (week 0) to week 31
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)
Time Frame: From baseline (week 0) to week 31
Number of episodes.
From baseline (week 0) to week 31
Time spent < 3.0 mmol/L (54 mg/dL)
Time Frame: From week 22 to 26
% of time.
From week 22 to 26
Change in time spent > 10.0 mmol/L (180 mg/dL)
Time Frame: From baseline (week-4 to 0) to week 22-26
% of time.
From baseline (week-4 to 0) to week 22-26
Mean weekly insulin dose
Time Frame: From week 24 to week 26
Units (U).
From week 24 to week 26
Change in body weight
Time Frame: From baseline (week 0) to week 26
Kilogram (kg).
From baseline (week 0) to 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

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 19, 2024

Primary Completion (Actual)

May 8, 2025

Study Completion (Actual)

June 13, 2025

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-7724
  • U1111-1292-6151 (Other Identifier: World Health Organization (WHO))
  • 2023-506084-34 (Other Identifier: European Medical Agency (EMA))

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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