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 a new medicine helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of the investigational medication. Which treatment participants will receive is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.
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 to 75 years of age at the time of providing informed consent
- Have a BMI greater than or equal to 23 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 180 days before screening.
- Have been receiving Stable daily dose(s) more than or equal 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without sodium-glucose co-transporter 2 (SGLT2) inhibitor.
- Glycated hemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
You may not qualify to participate if you:
- 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. 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.
- Have any known hypoglycemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.
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.
