NCT07076199

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 877 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Insulin icodec	Insulin icodec will be administered as subcutaneous injection
DRUG	Insulin glargine	Insulin glargine will be administered as subcutaneous injection.
DRUG	Insulin aspart	Insulin aspart will be administered as a subcutaneous injection.

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-01-25
• Completion: 2027-03-01
• First posted: 2025-07-22
• Last updated: 2026-04-06

Locations

193 sites across 8 countries: United States, Australia, Canada, Germany, Poland, Puerto Rico, Romania, Slovakia

Regulatory

• FDA-regulated drug study