GLPwatch

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)

NCT06269107 · Completed

Last updated 2026-05-28

This study is testing how well a new once-weekly injectable medicine (IcoSema) controls blood sugar levels in adults with type 2 diabetes compared to a daily insulin injection.

Status Completed The study has finished.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, open-label (no blinding) treatment study
Participants 485 people
Who can join Ages 18+ · all sexes
Timeline Started 2024-02 · est. completion 2025-07
Where 100 sites · China, Greece, India, Italy, Japan, Poland, Puerto Rico, South Africa, Turkey (Türkiye), United States

What this study is testing ClinicalTrials.gov NCT06269107 ↗

Description as written by the study sponsor.

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).

Treatments tested

Main thing measuredChange in glycated haemoglobin (HbA1c)
SponsorNovo Nordisk A/S
Conditions studiedType 2 Diabetes
GLP-1 drugs semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06269107 ↗