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Type 2

Once-Weekly Basal Insulin Combined with Semaglutide Could Help Lower Glucose Levels

3 Minute Read
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This clinical trial is testing whether IcoSema, a new once-weekly insulin injection combined with semaglutide, can help people with type 2 diabetes better manage their glucose levels and lose weight. 

Clinical Trials Identifier: NCT06269107

Trial Name: 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, Compared to Daily Insulin Glargine (COMBINE 4)

Diabetes type: Adults with type 2 diabetes

Trial Sponsor: Novo Nordisk

What is the trial testing?

This study is enrolling around 474 participants with type 2 diabetes to study their glucose levels while taking IcoSema, a combination of semaglutide (a GLP-1 receptor agonist) and insulin icodec (a new ultra-long acting insulin currently being investigated in clinical trials). 

Participants will be randomly assigned to one of two groups: those receiving a once-weekly dose of IcoSema, and those receiving a daily basal insulin injection (insulin glargine). Treatment will be given by injection, regardless of group assignment. 

Researchers are measuring participants’ average change in A1C over the entire course of the trial (around 40 weeks). They are also measuring changes in body weight, number of severe episodes of hypoglycemia, changes in fasting glucose levels, and time in range. 

Why is this trial new and important?

The GLP-1 receptor agonist semaglutide (known by the brand names: Wegovy, Ozempic, and Rybelsus), has been shown to have several benefits for people with type 2 diabetes. It helps people lower their glucose levels, better manage their weight, and it has been shown to protect against diabetes-related complications such as heart disease. 

Ongoing research studies will investigate whether combining a once-weekly GLP-1 receptor agonists with once-weekly insulin as combination therapy may help people lower their overall insulin dose while maintaining the same or better glucose levels. Combinations of basal insulin and GLP-1 drugs have been successful in past clinical trials, however, they must be injected daily. 

There is a lot of excitement around the possibility of a once-weekly insulin injection, which could make it easier for people to stick to their treatment plan. In one study of people with type 2 diabetes, all of whom had an A1C above 9% and discontinued or never started using insulin, nearly 75% of participants reported issues with frequent injections as a main reason to not use insulin. A once-weekly dose could replace the need for multiple daily injections and may help people with diabetes take their medications more consistently.

Trial locations: This is a multicenter, worldwide study with 110 locations across the United States, Italy, India, Japan, South Africa, and several other countries. 

Are you interested? 

You may be eligible to participate in this study if you:

  • Are an adult with type 2 diabetes 18 years or old, diagnosed at least 180 days before the pre-trial screening
  • Have an A1C of 8% or higher
  • Is new to insulin
  • Are currently being treated with 1-3 oral diabetes drugs (for at least 90 days before screening)
  • Are not currently pregnant, breastfeeding, or intending to become pregnant
  • Have not had an episode of diabetic ketoacidosis within 90 days of the pre-trial screening.

You can see a full list of inclusion/exclusion criteria here. 

To learn more, you can contact the Novo Nordisk study team at [email protected] or call (+1) 866-867-7178.