Do you have type 2 diabetes and are currently struggling with weight related issues?
This clinical research study is evaluating an experimental treatment for type 2 diabetics. This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with these conditions, and whether it will be made widely available to all Canadians trying to manage them. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are 18 years of age or older at the time of joining the study
- Have a BMI greater than or equal to 27.0 kg/m^2 (You can calculate your BMI using this tool: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm
- Have been diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before joining the study
- Are currently treating your diabetes with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
- Are currently being treated with oral antidiabetic drugs, dosage should be stable for at least 90 days before joining the study
You may not qualify to participate if you:
- Have clinically significant or severe hypoglycemia within 6 months before screening or history of hypoglycemia unawareness
- Have renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured by the central laboratory at screening
- Have uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.