NCT06340854

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Insulin icodec	Insulin Icodec will be administered subcutaneously.
DRUG	Insulin glargine	Insulin glargine will be administered subcutaneously.

Timeline

• Start date: 2024-04-19
• Primary completion: 2025-05-08
• Completion: 2025-06-13
• First posted: 2024-04-02
• Last updated: 2026-04-09

Locations

72 sites across 9 countries: United States, Bulgaria, Germany, India, Japan, Poland, Puerto Rico, South Africa, Spain

Regulatory

• FDA-regulated drug study