About this study
Do you have type 2 diabetes and are currently taking Semaglutide or Tirzepatide to control your glucose levels?
This clinical research study is evaluating an experimental treatment for type 2 diabetics.
The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with the experimental medication compared with placebo in participants with type 2 diabetes who are not at their HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
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.
Who may qualify
You may qualify if
- Have type 2 diabetes
- Have HbA1c ≥7.5% to ≤10.5% at screening
- Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
- Have had a stable body weight for the three months prior to screening
- Are on a stable treatment dose of one of the following incretins for at least three months:
- Injectable semaglutide (1 and 2 milligram (mg))
- Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg
This study may not be a fit if
- Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
- Have a prior or planned surgical treatment for obesity
- Have any of the following cardiovascular conditions within three months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure
- Have used insulin to control blood glucose within the past year (short-term use allowed)
- Any current use of another oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the additional OAM treatment was discontinued at least 3 months prior to screening
- If participant has been on stable doses (for at least three months) of up to three OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
- Have taken any medications or alternative remedies for weight loss within three months prior to screening
Every study has additional criteria the research site will review with you.
What participation may involve
- Regular visits with the study team at no cost
- Study assessments and health monitoring throughout
- Check-ins between visits
- Informed consent before anything begins — questions welcome
What participants may receive
- Study-related care from a physician-led team
- Study assessments at no cost
- Reimbursement for reasonable travel, where applicable
Specifics vary by study and site, and are never a guarantee of benefit. Being in a study is not a substitute for regular medical care.