NCT04848480

A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (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) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken. At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	insulin icodec	insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly
DRUG	insulin degludec	insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily
DRUG	insulin aspart	insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-04-28
• Completion: 2022-12-02
• First posted: 2021-04-19
• Last updated: 2025-12-04
• Results posted: 2025-06-12

Locations

130 sites across 12 countries: United States, Austria, Canada, Germany, India, Italy, Japan, Netherlands, Russia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study