Diabetes is a condition in which your blood glucose, or blood sugar, levels are too high. With type 2 diabetes, the more common type, your body does not make or use insulin well. Insulin is a hormone that helps glucose get into your cells to give them energy. Without insulin, too much glucose stays in your blood. Over time, high blood glucose can lead to serious problems with your heart, eyes, kidneys, nerves, and gums/teeth.
Do you have type 2 diabetes?
This clinical research study is looking at the safety and effectiveness of an investigational medication option for volunteers with type 2 diabetes.
Would you like to take part in type 2 diabetes research?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your diabetes to monitor the safety and effectiveness of the care you’ll receive. 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 screening
- Have been diagnosed with Type 2 Diabetes
- Have an HbA1c of between 7.0% and 10.5% inclusive at time of screening
- Have been receiving a stable treatment of at least 1 antihyperglycemic medication for at least 3 months prior to screening, and willing to continue the treatment for the duration of the study. Up to 3 of these antihyperglycemic medications are acceptable:
- DPP-4 inhibitors
- SGLT2 inhibitors
- biguanides, such as metformin
- alpha-glucosidase inhibitors
- GLP-1 receptor agonists, oral or injectable
- Have not used Insulin to treat your diabetes. Exceptions include:
- short-term insulin treatment for a maximum of 14 days, prior to screening
- prior insulin treatment for gestational diabetes
- Are willing and able to follow study procedures as required, such as:
- self inject interventional medication
- store and take provided study interventions as directed
- maintain an electronic study diary
- use only the glucometer supplied for use in this study
- wear a CGM device as directed
You may not qualify to participate in this study if you:
- Have a diagnosis of Type 1 Diabetes, latent autoimmune diabetes, or specific type of diabetes other than Type 2
- Have a history of more than 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening
- Have had severe hypoglycemia episodes within 6 months prior to screening
- Have a history of renal transplantation or are currently receiving renal dialysis
- Have had a blood transfusion or significant blood loss within 90 days prior to screening
- Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- Have experienced heart failure or any of the following cardiovascular conditions within the past 3 months prior to screening:
- Acute myocardial infarction
- cerebrovascular accident (stroke)
- coronary bypass surgery
- Have experienced significant weight gain or loss within 3 months prior to screening, for example and greater than 5% change
- Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
- Have a history of an active or untreated cancer malignancy or are in remission from a clinically significant malignancy within 5 years prior to screening
- Are at an increased risk for developing cancer or a recurrence of cancer
There are other eligibility requirements that the study doctor will review. Only the study doctor can determine whether you are eligible to participate in the study or not.
Fill out our diabetes questionnaire for priority access to all our diabetes studies: https://joinastudy.ca/questionnaire/diabetes/