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Do you have type 2 diabetes and are currently struggling with weight and blood sugar related issues?
This clinical research study is evaluating an experimental treatment for type 2 diabetics. This study will look at how well 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 medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
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 to manage type 2 diabetes, and whether it will be made widely available to all Canadians. 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 providing informed consent
- Have a BMI greater than or equal to 30 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 ≥ 180 days before screening
- Have been taking stable, daily doses of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator for ≥ 90 days before screening visit:
- Metformin with or without an SGLT2 inhibitor
- Have HbA1c between 7.0 – 10.5% (both inclusive) as determined by a central laboratory at screening
You may not qualify to participate if you:
- Are pregnant, breast-feeding or intend to become pregnant, or are of child-bearing potential and not using a highly effective contraceptive method
- Experience renal impairment
- Have been treated with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
- Have uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
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.
