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Study 2 consisted of 50 healthy subjects (ages 18-45) who were randomized to receive 40, 100, 150, 200, 300 or 400 mg saxagliptin or matching placebo once daily for 14 days. Within each panel, 6 subjects received 100, 150, 200, 300 or 400 mg saxagliptin, 2 subjects received 40 mg saxagliptin and 2 subjects received matching placebo.
In both studies, there were no deaths or serious adverse events. Additionally, no adverse events of hypoglycemia were reported by investigators. In Study 2, one participant experienced an adverse event (mild rash), which resulted in discontinuation from the study while taking 200 mg of saxagliptin once daily.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes, accounting for approximately 90-95 percent of diabetes cases. Having Type 2 diabetes increases the risk of many serious complications, including heart disease or stroke, high blood pressure, amputation (particularly legs), blindness, nerve damage, and kidney failure. The risk of stroke and the rate of deaths due to heart disease are two to four times higher among people with diabetes, and about 65 percent of deaths among people with diabetes are due to heart disease and stroke.
The A1C test (also known as hemoglobin A1C) is used primarily to monitor the glucose control of diabetics over time. The goal of those with diabetes is to keep their blood glucose levels as close to normal as possible. This helps to minimize the complications caused by chronically elevated glucose levels, such as progressive damage to body organs like the kidneys, eyes, cardiovascular system, and nerves. The A1C test gives a picture of the average amount of glucose in the blood over the last few months. It can help a patient and his doctor know if the measures they are taking to control the patient's diabetes are successful or need to be adjusted.
About Saxag
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