This Phase Ib study was designed to assess the safety, tolerability and pharmacokinetics of once-daily, orally administered doses of either 2.5gm or 5gm of SRT501 in patients with type 2 diabetes who were naive to other diabetes drug treatments. Both doses of SRT501 were found to be safe and well-tolerated, and pharmacokinetics, a measure of drug levels in the blood, were identical at days one and 28, suggesting no drug accumulation. There were no serious adverse events and no dose-related adverse events.
Peter Elliott, senior vice president of development at Sirtris, said: “These Phase Ib study results are an important step forward for Sirtris because they represent significant progress in our clinical development of sirtuin therapeutics. We are very pleased to see the safety profile observed in preclinical studies translate into a well-tolerated drug molecule in patients, and we are very encouraged by the glucose lowering effects measured in the oral glucose test.”