This study is comparing the effectiveness of two different doses of semaglutide (Ozempic) in patients with Type 2 diabetes (T2D). The main outcome to be measured will be the change in HbA1c (average blood glucose levels over 3 months).
The details
One of the goals of treatment for patients with T2D is to improve glycemic (blood sugar) control. Semaglutide is a non-insulin medicine that can help. Semaglutide helps the body make more insulin, which then helps lower blood sugar levels. Semaglutide is given as a once-weekly injection.
This study is comparing two doses (1.0 mg and 2.0 mg) of semaglutide to see which is more effective for patients with T2D. The main outcome to be measured will be the change in HbA1c levels from the beginning of the study to the end of the study.
Who are they looking for?
This study is recruiting 964 adults with T2D. Patients should have been diagnosed with T2D within 6 months of enrolling in the study. Patients should be on stable anti-diabetes therapy for at least 90 days before the study. This therapy should include metformin-based drugs with or without sulfonylureas, another type of anti-diabetes medication.
Patients taking any other medications for diabetes within 90 days of beginning the study cannot participate. Only short-term insulin use for up to 2 weeks is allowed. Patients with poor kidney function and uncontrolled eye problems related to diabetes cannot participate. Women who are pregnant, breast-feeding, or intending on becoming pregnant cannot participate.
How will it work
This study will have two groups of patients. In the first group, patients will receive 1.0 mg of semaglutide. In the second group, patients will receive 2.0 mg of semaglutide. Patients will be taking semaglutide once a week via injection in addition to their regular anti-diabetes medication. This study will take place over 49 weeks.
During the study, patients will have 9 clinic visits and 2 phone calls with a study doctor. During the clinic visits, patients will have blood tests and eye exams. Female patients with a chance of becoming pregnant will have urine pregnancy tests. Effectiveness of 1.0 mg versus 2.0 mg of semaglutide will be measured using changes in HbA1C levels. Fasting blood sugar levels, body weight, and side effects will also be measured.
