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NCT06269107 · ClinicalTrials.gov registry record · Phase 3

A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)

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

Completed
Registry status
Phase 3
Development phase
485
Enrollment target

NCT06269107: Completed Phase 3 study, sponsored by Novo Nordisk A/S.

NCT06269107 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 485 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06269107, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
485 participants
Enrollment target

Study Summary

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).

Primary Outcome

Measured in percentage (%)-point.

Interventions

  • DRUG Insulin glargine
  • DRUG IcoSema

Trial Details

FieldValue
Enrollment Target 485 participants
Start Date 2024-02-15
Est. Completion 2025-07-08
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT06269107 record still lists

NCT06269107 is an interventional study that assigns participants to a tested intervention. The registered 485 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 (37% lower).

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

NCT06269107 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06269107 about?

NCT06269107 is a clinical study titled "A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)". This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar lev...

What is the current status of trial NCT06269107?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2024-02-15. Estimated completion is 2025-07-08.

What interventions are being tested in trial NCT06269107?

The interventions under investigation include: Insulin glargine (DRUG), IcoSema (DRUG).

Who is sponsoring clinical trial NCT06269107?

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 NCT06269107's enrollment target sits among peer trials

485 790th of 2000 higher than 1,210 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 NCT06269107, the US trial registry maintained by the National Library of Medicine. NCT06269107 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.