CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 984 enrolled
Drug / intervention
Insulin icodec +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04460885
NCT04460885Phase 3Completed

A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Jul 8, 2020·Updated Dec 4, 2025

In Brief

A Phase 3 clinical trial evaluating Insulin icodec and Insulin glargine for Diabetes Mellitus, Type 2. Completed, enrolled 984 participants across 198 sites in 13 countries.

Detailed 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 get is decided by chance. 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 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 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 the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCroatia, India, Israel, Italy, Japan, Mexico, Poland, Puerto Rico, Russia, Slovakia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJul 8, 2020
Enrollment StartNov 25, 2020
Primary CompletionMay 29, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.0 years ago

Interventions

Insulin icodecdrug

Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.

Insulin glarginedrug

Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks