About the Studies
Hundreds of millions of people have diabetes worldwide– and those numbers continue to climb. Over 90% of people with diabetes have Type 2 Diabetes (T2D). It is one of the leading causes of heart disease, stroke, blindness, kidney disease, amputation and death.
Diet, exercise, and education are important in the management of T2D, but many people also require drug therapy to manage their illness. Maintaining blood glucose levels within the recommended range is a difficult goal to achieve without increasing your risk of hypoglycemia (low blood sugar).
Participants will be required to attend regular office visits throughout the duration of the SOTA studies. You will be given glucose monitoring supplies and asked to record your blood glucose levels and any symptoms you might be having in a diary. Participants will be required to fast, or go without food for 8 hours, prior to some visits during the study. You may also have the following assessments evaluated: physical exam, vital signs, blood and urine tests; and diet, exercise, and health education.
The SOTA studies are evaluating an investigational oral tablet that may help manage your blood glucose levels.
In the SOTA-GLIM study, you will randomly be assigned to receive the investigational oral tablet, glimepiride, or a placebo. You will be provided with kits containing either the study drug or placebo tablets, as well as, kits containing either glimepiride or placebo capsules. The oral tablets and capsules will be taken once before the first meal of the day. The placebo has no active drug in it. Neither you nor the person administering the drugs will know if you are receiving the study drug, glimepiride, or the placebo.