NCT04880850

A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine 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 glargine that participants will have to inject once a day at the same time every day. Which treatment participants will get is decided by chance. 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 8 months. participants will have 17 clinic visits and 13 phone calls with the study doctor.At 8 clinic visits participants will have blood samples taken. At 4 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 their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Insulin icodec	Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks
DRUG	Insulin glargine	Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 26 weeks
DRUG	Insulin aspart	Participants will receive subcutaneous (s.c.) injections of insulin aspart 2-4 times daily for 26 weeks

Timeline

• Start date: 2021-05-14
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2021-05-11
• Last updated: 2025-12-04
• Results posted: 2025-07-02

Locations

116 sites across 9 countries: United States, Belgium, India, Italy, Japan, Mexico, Netherlands, Romania, Russia

Regulatory

• FDA-regulated drug study