A possible replacement of Rosiglitazone and Pioglitazone for Type II Diabetes?
Findings from the Phase II SYNCHRONY study show that aleglitazar, a treatment for Type 2 diabetes, could be safe and effective and thus will be entered into Phase III trials. The data, already published online and forthcoming in The Lancet, were presented at the recent American Diabetes Association meeting in New Orleans, La.
Aleglitazar is in a class of drugs called PPAR coagonists, meaning it can affect both glucose and fat (lipid) control. It also shares functional similarities with the thiazolidinedione family of drugs, along with, for example, rosiglitazone and pioglitazone. Both rosiglitazone and pioglitazone are well documented as effective agents for blood glucose control in patients with Type 2 diabetes, but both also have a number of safety concerns attached to their use.
A number of PPAR coagonists developed so far have been discontinued owing to toxic effects.
Professor Robert R. Henry, University of California, San Diego, and colleagues—authors of SYNCHRONY—were hopeful that aleglitazar could have a similar positive effect on glucose control, but without the accompanying safety issues.
In the Phase II randomized study, patients with Type 2 diabetes (either drug-naïve or treated with two or fewer oral agents) were enrolled from 47 sites in seven countries. Following a five-week run in period with all patients on placebo, 332 were randomized to 16 weeks of treatment with aleglitazar at once-daily doses of 50, 150, 300, 600 µg, or matching placebo (55 in each group), or to pioglitazone 45 mg once daily (57 patients) as a reference. The primary endpoint was the change in glycosylated haemoglobin concentration (HbA1c) from baseline to the end of treatment.
The researchers found that aleglitazar reduced baseline HbA1c versus placebo in a dose-dependent manner, from -0.36 percent with 50 µg to -1.35 percent at 600 µg. The trend of changes over time suggested that the maximum effect of aleglitazar on HbA1c concentration was not yet reached after 16 weeks of treatment.
Source: EurekAlert! 6/8/09
