CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 588 enrolled / 588 target
Drug / intervention
Insulin icodec +3 moredrug
Likely dose
Insulin icodec 700 unitsfrom 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/NCT04795531
NCT04795531Phase 3CompletedMonitor (9.3/mo)Completion was 48mo ago

A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

Novo Nordisk A/S·interventional·Posted Mar 12, 2021·Updated Jun 12, 2026

In Brief

A Phase 3 clinical trial evaluating Insulin icodec, Placebo insulin icodec, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 588 participants across 190 sites in 12 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (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 degludec taken daily. Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get. The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 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. 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--
CountriesArgentina, Austria, Brazil, Canada, China, Czechia, Denmark, France, Mexico, Puerto Rico, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 12, 2021
Enrollment StartMar 24, 2021
Primary CompletionJun 23, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.3 years ago

Arms & Interventions

Once weekly insulin icodec + once daily placeboexperimental

Participants will get once daily and once weekly injections

Drug: Insulin icodecDrug: Placebo insulin degludec
Once weekly placebo and once daily insulin degludecexperimental

Participants will get once daily and once weekly injections

Drug: Placebo insulin icodecDrug: Insulin degludec

Interventions

Insulin icodecdrug

You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections

Placebo insulin icodecdrug

You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections

Insulin degludecdrug

You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections

Placebo insulin degludecdrug

You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections