CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 582 enrolled
Drug / intervention
Insulin icodec +2 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/NCT04880850
NCT04880850Phase 3Completed

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

Novo Nordisk A/S·interventional·Posted May 11, 2021·Updated Dec 4, 2025

In Brief

A Phase 3 clinical trial evaluating Insulin icodec, Insulin glargine, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 582 participants across 116 sites in 9 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, India, Italy, Japan, Mexico, Netherlands, Romania, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMay 11, 2021
Enrollment StartMay 14, 2021
Primary CompletionJun 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.1 years ago

Interventions

Insulin icodecdrug

Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks

Insulin glarginedrug

Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 26 weeks

Insulin aspartdrug

Participants will receive subcutaneous (s.c.) injections of insulin aspart 2-4 times daily for 26 weeks