Type 2 Diabetes and SRT501
Disease background and scientific rationale
Type 2 Diabetes, formerly known as adult-onset diabetes, accounts for approximately 90 percent of all diagnosed diabetes patients. It is a disease associated with aging and is more prevalent in patients with a high percentage of body fat. Type 2 Diabetes is manifested by an inability of the body's peripheral tissues, such as muscle and adipose, or fat, to respond to insulin. Normally, insulin stimulates uptake and utilization of blood glucose in muscle and adipose tissue, thereby regulating serum, or blood glucose levels. Type 2 diabetics have decreased sensitivity to insulin and, as a result, high glucose levels. On a cellular level, patients with Type 2 Diabetes also appear to have impaired mitochondrial function, and, we believe, an imbalance between mitochondrial activity and calorie intake.
Many approved drugs for Type 2 Diabetes are associated with side effects such as weight gain and hypoglycemia. We believe that none of these drugs treat what appears to be an underlying cause of the disease, an imbalance between mitochondrial activity and calorie intake. Our studies have shown that SRT501 decreases fasted glucose levels and fed insulin levels in animal models of diabetes. We have also shown that SRT501 increases mitochondrial activity in animals, and that SRT501 is safe and well-tolerated. We believe that SIRT1 activators such as SRT501 may prove useful in treating Type 2 Diabetes either alone or in combination with current therapies.
Clinical trials
In two Phase I and two Phase IIa human clinical trials, SRT501 was found to be safe and well tolerated. In the Phase IIa human trials, SRT501 also lowered glucose and improved insulin sensitivity of patients with Type 2 Diabetes.
SRT501 is also being tested in a Phase IIa study in Type 2 diabetic males in order to determine the safety, PK and efficacy of SRT501 together with metformin, current front-line therapy for Type 2 Diabetes.
We expect data from this Phase IIa study by the first half of 2009.
Results from these clinical trials will enhance our understanding of SRT501 and will serve as the basis for determining the development path for SRT501 in Type 2 Diabetes.
To help you learn more about Type II Diabetes, we have provided the web links below:
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