Islet Sciences reports results from two Phase IIb clinical studies for type 2 diabetics drug

The two Phase IIb clinical studies were double-blind, pioglitazone-controlled, dose-ranging studies designed to assess the safety, efficacy and tolerability of multiple remogliflozin etabonate doses for 12-weeks in treatment-naïve subjects with type 2 diabetes.

In one study remogliflozin etabonate, a selective SGLT2 inhibitor indicated for type 2 diabetes and NASH, was dosed once daily, while in the second study remogliflozin etabonate was dosed twice-daily over the 12-week study period.

Primary end point of the studies was HbA1c. Secondary end points included fasting plasma glucose, serum lipids, body weight, safety and tolerability.

Islet Sciences COO Dr William Wilkison noted that the results of these two studies are very positive in their own right, but what’s exciting is the additional formulation work the company has done as a result of what it has learned from these data.

"Based on our phase 2b results, we have learned more about the biology of the mechanism and have developed a once-daily formulation that will maximize the effect on post-prandial glucose and therefore efficacy, while reducing side-effects commonly associated with inhibition of SGLT2.

"And at the same time, with a selective SGLT2 inhibitor we avoid the potential side effects of the more broadly expressed SGLT1 gene which appears to play a role in glucose modulation in cardiac tissue," Dr Wilkison added.

Islet Sciences will present the full results of the two Phase IIb clinical studies at the 74th American Diabetes Association Scientific Sessions in San Francisco, 13 June to 17 June 2014.