CagriSema for Type 2 Diabetes
(REIMAGINE 3 Trial)
Trial Summary
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.
What data supports the effectiveness of the drug CagriSema for treating type 2 diabetes?
Is CagriSema safe for humans?
Semaglutide, a component of CagriSema, has been studied for type 2 diabetes and obesity, showing common gastrointestinal side effects and rare cases of pancreatitis (inflammation of the pancreas), diabetic retinopathy (eye damage), and severe allergic reactions. These studies suggest it is generally safe but can have side effects.45678
What makes the drug CagriSema unique for treating type 2 diabetes?
What is the purpose of this trial?
This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.
Research Team
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Eligibility Criteria
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
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
Treatment Details
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