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NCT04770532 · ClinicalTrials.gov registry record · Phase 3

A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin

A Phase 3 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
526
Enrollment target

NCT04770532: Completed Phase 3 study, sponsored by Novo Nordisk A/S.

NCT04770532 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 526 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04770532, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
526 participants
Enrollment target

Study 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 either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin degludec 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 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.

Primary Outcome

Change in HbA1c from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for part

Interventions

  • DRUG Insulin Icodec
  • DRUG Insulin degludec

Trial Details

FieldValue
Enrollment Target 526 participants
Start Date 2021-03-05
Est. Completion 2022-03-01
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT04770532 record still lists

NCT04770532 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which Insulin Icodec is the first listed.

NCT04770532 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04770532 about?

NCT04770532 is a clinical study titled "A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin". 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 deglud...

What is the current status of trial NCT04770532?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 526 participants. The study started on 2021-03-05. Estimated completion is 2022-03-01.

What interventions are being tested in trial NCT04770532?

The interventions under investigation include: Insulin Icodec (DRUG), Insulin degludec (DRUG).

Who is sponsoring clinical trial NCT04770532?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04770532's enrollment target sits among peer trials

526 715th of 2000 higher than 1,286 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04770532, the US trial registry maintained by the National Library of Medicine. NCT04770532 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.