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

Completed · Phase 3

Conditions studied: Diabetes, Type 2

In brief

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.

Key facts

Study ID

NCT06340854

Run by

Novo Nordisk A/S

People needed

412

Starts

2024-04-19

Expected to finish

2025-06-13

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Advanced Investigative Medicine, Inc. — Hawthorne, California, United States
• Scripps Whittier Diabetes Inst — La Jolla, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Northeast Research Institute of Florida — Fleming Island, Florida, United States
• South Broward Research LLC — Miramar, Florida, United States
• Endo Res Solutions Inc — Roswell, Georgia, United States
• Rocky Mountain Diab&Osteo Ctr — Idaho Falls, Idaho, United States
• Velocity Clinical_Valparaiso — Valparaiso, Indiana, United States
• Iowa Diab & Endo Res Center — West Des Moines, Iowa, United States
• Cotton-Oneill Diabetes and End — Topeka, Kansas, United States
• International Diabetes Center — Minneapolis, Minnesota, United States
• Jefferson City Medical Group, PC — Jefferson City, Missouri, United States
• Univ of Nebraska Medical CTR — Omaha, Nebraska, United States
• Palm Research Center Inc-Vegas — Las Vegas, Nevada, United States
• Southern NH Diabetes and Endo_Nashua — Nashua, New Hampshire, United States
• PharmQuest Life Sciences LLC — Greensboro, North Carolina, United States
• Accellacare Wilmington — Wilmington, North Carolina, United States
• Trial Management Associates — Myrtle Beach, South Carolina, United States
• Amarillo Medical Specialists — Amarillo, Texas, United States
• Velocity Clinical Res-Dallas — Dallas, Texas, United States
• Diabetes and Thyroid Ctr of FW — Fort Worth, Texas, United States
• Victorium Clinical Research — Houston, Texas, United States
• PlanIt Research, PLLC — Houston, Texas, United States
• Chrysalis Clinical Research — St. George, Utah, United States
• Valley Research — Fresno, California, United States

Full record on ClinicalTrials.gov

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