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

NCT06340854 | Completed Phase 3 FDA Drug

• 3 other identifiers: NN1436-7724U1111-1292-61512023-506084-34
• Study Type: interventional
• Target: 429
• Locations: 9 countries
• Sites: 72

Brief Summary

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.

Conditions

Diabetes, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in glycated hemoglobin (HbA1c)

  Percentage point (%-point).

  From baseline (week 0) to week 26

Secondary Outcomes (9)

• Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL))

  From baseline (week -4 to 0) to week 22-26

• Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction

  From baseline (week 0) to week 26

• Number of severe hypoglycaemic episodes (level 3)

  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)

  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

Study Arms (2)

Insulin icodec

EXPERIMENTAL

Participants will receive Insulin icodec subcutaneously once weekly.

Drug: Insulin icodec; Drug: Insulin glargine

Insulin glargine U100

ACTIVE COMPARATOR

Participants will receive Insulin glargine subcutaneously once daily.

Drug: Insulin icodec; Drug: Insulin glargine

Interventions

Insulin icodec DRUG

Insulin Icodec will be administered subcutaneously.

Insulin glargine U100; Insulin icodec

Insulin glargine DRUG

Insulin glargine will be administered subcutaneously.

Insulin glargine U100; Insulin icodec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (72)

Advanced Investigative Medicine, Inc.

Hawthorne, California, 90250, United States

Location

Scripps Whittier Diabetes Inst

La Jolla, California, 92037, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Northeast Research Institute of Florida

Fleming Island, Florida, 32003, United States

Location

South Broward Research LLC

Miramar, Florida, 33027, United States

Location

Endo Res Solutions Inc

Roswell, Georgia, 30076, United States

Location

Cotton-Oneill Diabetes and End

Topeka, Kansas, 66606-2806, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Jefferson City Medical Group, PC

Jefferson City, Missouri, 65109, United States

Location

Univ of Nebraska Medical CTR

Omaha, Nebraska, 68198-3020, United States

Location

Palm Research Center Inc-Vegas

Las Vegas, Nevada, 89148, United States

Location

Southern NH Diabetes and Endo_Nashua

Nashua, New Hampshire, 03060, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Accellacare Wilmington

Wilmington, North Carolina, 28401, United States

Location

Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States

Location

Amarillo Medical Specialists

Amarillo, Texas, 79124, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

Victorium Clinical Research

Houston, Texas, 77024, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States

Location

Medical Center Viva Feniks OOD

Dobrich, 9300, Bulgaria

Location

MHAT Knyaginya Klementina - Sofia EAD

Sofia, 1233, Bulgaria

Location

UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

Sofia, 1431, Bulgaria

Location

Medical Institute of Ministry of interior

Sofia, 1606, Bulgaria

Location

Medical Centre - Clinic Nova EOOD

Varna, 9000, Bulgaria

Location

MC Berbatov EOOD, Beli Drin

Yambol, 8600, Bulgaria

Location

InnoDiab Forschung GmbH

Essen, 45136, Germany

Location

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany

Location

MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

Münster, 48153, Germany

Location

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, 23758, Germany

Location

Institut für Diabetesforschung Osnabrück

Osnabrück, 49080, Germany

Location

Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, 88239, Germany

Location

Lifecare Hospital and Research Centre

Bangalore, Karnataka, 560092, India

Location

Belgaum Diabetes Centre

Belagavi, Karnataka, 590001, India

Location

Manipal Hospital, Old Airport Road, Bengaluru

Bengaluru, Karnataka, 560017, India

Location

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, 452010, India

Location

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Chellaram Diabetes Institute

Pune, Maharashtra, 411021, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Puducherry, Tamil Nadu, 605006, India

Location

Gandhi Hospital & Medical college

Hyderabad, Telangana, 500003, India

Location

Malla Reddy Narayana Multispeciality Hospital

Hyderabad, Telangana, 500055, India

Location

Government Institute of Medical Sciences

Noida, Uttar Pradesh, 201310, India

Location

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

Chandigarh, 160012, India

Location

Christian Medical College and Hospital

Ludhiana, 141008, India

Location

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, 880-0034, Japan

Location

Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology

Shinjuku-ku, Tokyo, Tokyo, 160-0023, Japan

Location

Futata Tetsuhiro Clinic Meinohama_Internal medicine

Fukuoka-shi, Fukuoka, 819-0006, Japan

Location

Oyama East Clinic_Internal Medicine

Tochigi, 323-0022, Japan

Location

Noritake Clinic

Ushiku-shi, Ibaraki, 300-1207, Japan

Location

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Opole Voivodeship, 45-401, Poland

Location

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

Bialystok, Podlaskie Voivodeship, 15-435, Poland

Location

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, 02-507, Poland

Location

Trialmed CRS

Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland

Location

Advanced Clinical Research LLC

Bayamón, 00959, Puerto Rico

Location

Manati Ctr For Clin Research

Manatí, 00674, Puerto Rico

Location

Hemant Makan

Johannesburg, Gauteng, 1827, South Africa

Location

Dr Moosa's Rooms

Lenasia, Gauteng, 1827, South Africa

Location

Botho ke Bontle Health Services

Pretoria, Gauteng, 0184, South Africa

Location

Dr A Amod

Durban, KwaZulu-Natal, 4092, South Africa

Location

Dr MB Moosa's Practice

Durban, KwaZulu-Natal, 4092, South Africa

Location

Dr Mahesh Duki Research And Trial Site

Durban, KwaZulu-Natal, 4339, South Africa

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

ABS La Roca del Vallés_Endocrinología

La Roca Del Vallés, 08430, Spain

Location

H. Clinico Univ. Virgen de la Victoria

Málaga, 29010, Spain

Location

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: April 19, 2024
• Primary Completion: May 8, 2025
• Study Completion: June 13, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (21); ES (5); BU (6); DE (6); PR (2); JP (5); PL (7); IN (14); ZA (6)