Sirtris reports positive results of Phase Ib trial of diabetic drug

The Phase Ib clinical trial, which tested either 1.25 or 2.5 grams of SRT501 given twice daily to Type 2 diabetic patients, found that the patient group receiving 2.5 grams twice a day had significantly lower blood glucose levels as determined through an oral glucose tolerance test (OGTT) at the test’s two-hour time point, as compared with the placebo group.

At 2.5 grams twice daily, the study also found that SRT501 had a statistically significant lowering of both fasting blood glucose and glucose levels after meals, known as the postprandial period, an important timeframe for Type 2 diabetics who need better control of blood sugar levels after eating. While not at the level of statistical significance, this dose level also showed a strong trend in lowering postprandial insulin levels.

At 1.25 grams given twice daily, SRT501 also showed strong trends. While not at statistical significance, SRT501 at 1.25 grams given twice per day lowered fasting and postprandial glucose, and glucose when challenged with an OGTT at the two-hour time point on day 27 of the trial as compared to the placebo group. The data suggest a dose response.

The current multi-center, blinded and randomized Phase Ib study included approximately 100 Type 2 diabetic patients divided into three groups. The first patient group received 1.25 grams of SRT501 twice daily for a total daily-dose level of 2.5 grams. The second patient group received 2.5 grams twice daily for a total daily-dose level of 5 grams. The third group received placebo twice daily. In both patient cohorts receiving SRT501, the drug was found to be safe and well-tolerated, with no evidence of drug accumulation. The study indicated that suitable pharmacokinetics, a measure of drug levels in the blood, was also achieved.