NCT06269107

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 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	IcoSema	IcoSema will be administered subcutaneously.
DRUG	Insulin glargine	Insulin glargine will be administered subcutaneously.

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-05-27
• Completion: 2025-07-08
• First posted: 2024-02-21
• Last updated: 2026-04-09

Locations

100 sites across 10 countries: United States, China, Greece, India, Italy, Japan, Poland, Puerto Rico, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study