The main purpose of the trial is to understand the effects of an investigational drug versus a placebo drug—the trial will measure the heart health of patients who take the study drug versus the placebo. The AMPLITUDE-O Trial is seeking Type 2 Diabetic patients with cardiovascular (CV) disease or kidney disease who are at an elevated risk of heart attack or stroke.
The AMPLITUDE-O Trial will also measure if the trial drug does not increase the risk of having a heart attack or stroke, versus taking a placebo. Additionally, the trial will measure if the study drug is better than a placebo for new or worsening kidney disease in patients at risk for heart attack or stroke.
During the trial, changes in blood sugar level (HBA1c) will be measured. In addition, other measurements during the trial will include changes in body weight, changes in blood pressure and changes in labs for kidney function.
Those who qualify to participate in clinical trials may receive study medication and study related medical care at no cost. People who participate in clinical trials aid others with the same condition by helping the scientific community find new treatment options for diseases such as Type 2 Diabetes.