CagriSema for Type 2 Diabetes
(REIMAGINE 3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine called CagriSema, a combination of Semaglutide and Cagrilintide, to determine if it can help people with type 2 diabetes lower their blood sugar and lose weight. Participants will receive either CagriSema or a placebo (a "dummy" medicine without active ingredients) alongside their usual diabetes medication. This study may suit individuals with type 2 diabetes who have maintained a stable insulin routine and possibly metformin for the last few months. By joining, participants will help researchers assess how well CagriSema works compared to a placebo. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
You can continue taking your current diabetes medications, like once-daily insulin and metformin, during the trial. However, if you are on other diabetes or obesity medications, you may need to stop those before joining.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CagriSema, a combination of cagrilintide and semaglutide, is generally safe for people with type 2 diabetes. In earlier studies, participants experienced significant weight loss without serious side effects. One study found that CagriSema led to more weight loss than using either semaglutide or cagrilintide alone, and it was well-tolerated by participants.
Some mild side effects, such as stomach issues, were reported, but these were uncommon and did not lead to discontinuation of the treatment. These findings suggest that CagriSema is safe for most people, but discussing any concerns with a healthcare provider is always important.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CagriSema for Type 2 Diabetes because it combines two active ingredients, cagrilintide and semaglutide, offering potential benefits over standard treatments like metformin, sulfonylureas, and insulin. Unlike these standard treatments, CagriSema incorporates cagrilintide, a novel amylin analog, which may help regulate appetite and improve blood sugar control. Additionally, semaglutide is a GLP-1 receptor agonist known for its effectiveness in lowering blood sugar and promoting weight loss. This combination aims to address multiple aspects of diabetes management, potentially providing improved outcomes for patients.
What evidence suggests that CagriSema might be an effective treatment for type 2 diabetes?
Research has shown that CagriSema, a combination of cagrilintide and semaglutide, can significantly aid people with type 2 diabetes in managing their weight and blood sugar. In earlier studies, participants using CagriSema lost up to 15.7% of their body weight, marking a significant reduction. Additionally, about 74% of participants achieved a blood sugar level of 6.5% or lower, a key target for diabetes management. In this trial, participants will receive either CagriSema at varying doses or a placebo. These findings suggest that CagriSema not only aids in weight loss but also enhances blood sugar control, making it a promising treatment for type 2 diabetes.12567
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for people with type 2 diabetes who are already taking once-daily basal insulin, with or without metformin. Participants should not be on any other diabetic medications and must have a stable dose of insulin for at least 90 days prior to the start of the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive once-weekly subcutaneous injections of CagriSema or placebo for up to 40 weeks, with dose escalation periods for active comparators
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cagrilintide
- Placebo
- Semaglutide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen