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

August 10, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
    • Gujarat
      • Ahmedabad, Gujarat, India, 390013
        • Swasthya Diabetes Care
    • 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
      • Saidābād, Telangana, India, 500059
        • FS Endocrine and diabetes Center
    • 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
      • Grudziądz, Poland, 86-300
        • NZOZ Euromedica Sp. z o.o.
      • 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
      • Manati, Puerto Rico, 00674
        • Manati Ctr For Clin Research
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Medi-Clinic Bloemfontein
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1827
        • Hemant Makan
      • Johannesburg, Gauteng, South Africa, 2198
        • Centre for Diabetes
      • 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 CAP Vicenç_Endocrino
      • 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
      • Fresno, California, United States, 93720
        • Valley Research
      • Hawthorne, California, United States, 90250
        • Advanced Investigative Medicine, Inc.
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • Lincoln, California, United States, 95648
        • Headlands Research CTR Lincoln
    • 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
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Rocky Mountain Diab&Osteo Ctr
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Velocity Clinical_Valparaiso
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diab & Endo Res Center
    • 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
      • Fort Worth, Texas, United States, 76132
        • Diabetes and Thyroid Ctr of FW
      • 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
      • Olympia, Washington, United States, 98502
        • Capital Clin Res Ctr,LLC
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 26
Change in HbA1c from week 0 to week 26 in percentage point is presented.
Week 0, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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: week -4-0, week 22-26
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.
week -4-0, week 22-26
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction
Time Frame: week 0 to week 26
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.
week 0 to week 26
Number of Severe Hypoglycaemic Episodes (Level 3)
Time Frame: From baseline (week 0) to week 31
Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.
From baseline (week 0) to week 31
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)
Time Frame: 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) from baseline (week 0) to week 31 is presented.
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 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.
From baseline (week 0) to week 31
Time Spent < 3.0 mmol/L (54 mg/dL)
Time Frame: Week 22-26
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.
Week 22-26
Change in Time Spent > 10.0 mmol/L (180 mg/dL)
Time Frame: Week -4-0, Week 22-26
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.
Week -4-0, Week 22-26
Mean Weekly Insulin Dose
Time Frame: From week 24 to week 26
Mean weekly insulin dose from week 24 to week 26 is presented.
From week 24 to week 26
Change in Body Weight
Time Frame: Week 0, Week 26
Change in body weight from baseline (week 0) to (week 26) is presented.
Week 0, Week 26

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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