This was a multi-center, placebo-controlled study to compare the efficacy and safety of (study drug) to placebo in subjects with T2DM who have inadequate blood sugar control.
Approximately 210 male or female subjects with Type 2 Diabetes were enrolled across all sites in this potentially 24 week study. Subjects received diet and exercise counseling, physical examinations, vital signs, ECGs, laboratory testing and a glucometer with all testing supplies for the study’s duration.
Type 2 diabetes is the most common form of diabetes. With type 2 diabetes, your body does not use insulin properly. This is called insulin resistance. At first, the pancreas makes extra insulin to make up for it. But, over time your pancreas isn’t able to keep up and can’t make enough insulin to keep your blood glucose levels normal.
Type 2 diabetes is treated with lifestyle changes, oral medications (pills), and insulin. When glucose builds up in the blood instead of going into cells, it can cause two problems: Right away, your cells may be starved for energy. Over time, high blood glucose levels may hurt your eyes, kidneys, nerves or heart.
Some people with type 2 diabetes can control their blood glucose with healthy eating and being active. But, your doctor may need to also prescribe oral medications or insulin to help you meet your target blood glucose levels. Type 2 diabetes usually gets worse over time, even if you don’t need medications at first, you may need them later on. Some groups have a higher risk for developing type 2 diabetes than others. Type 2 diabetes is more common in African Americans, Latinos, Native Americans, and Asian Americans/Pacific Islanders, as well as the aged population.