NCT04760626

A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before

Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,085 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study compares insulin icodec to different daily insulins in people with type 2 diabetes. The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App. The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken. 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 52 weeks.
DRUG	Insulin Glargine 100U/mL	Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
DRUG	Insulin Degludec	Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
DRUG	Insulin Glargine 300U/mL	Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-08-12
• Completion: 2022-08-29
• First posted: 2021-02-18
• Last updated: 2025-09-03
• Results posted: 2025-08-26

Locations

180 sites across 8 countries: United States, Canada, Germany, Greece, Hungary, Poland, Puerto Rico, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study