Summary:
The COMBINE 1 study is a long-term study comparing the effect and safety of a once-weekly investigational combination product, IcoSema to that of a once-weekly investigational insulin, icodec over a period of 52 weeks plus 5 weeks of follow-up. This study is part of a global programme of clinical studies investigating how well a new investigational combination product taken once-weekly, IcoSema, affects blood sugar in people with type 2 diabetes compared to other insulins or semaglutide taken once-weekly or once‑daily, some of which are already available on the market. In all cases, insulins and semaglutide are administered using a pen via injection under the skin (subcutaneous injection).
By taking part in the COMBINE 1 study, you will be part of an international community of around 1300 people in approximately 21 countries around the world. It is expected that about 300 participants will be from the United States. You will be expected to visit your local study centre at AMCR Institute, Escondido, CA approximately 23 times during a period of 52 weeks plus 2 times during the 5 weeks of follow-up. By participating in the study, you can contribute to the understanding of type 2 diabetes and make a difference to your life and the lives of other people with type 2 diabetes.
Qualified Participants Must:
• You may qualify for this study if you are an adult with type 2 diabetes who has been treated with a once or twice-daily insulin.
Qualified Participants May Receive:
There might be compensation for all visits completed. Study participants would also receive study medication including pens and needles, a blood sugar meter, a CGM, an eDiary on a study phone, and training and care by a clinician at no costs.