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

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GlaxoSmithKline in February announced initiation and dosing of the first patient of the Phase III clinical trial programme to evaluate the efficacy, safety, and tolerability of the investigational GLP-1 (Glucagon-like peptide 1) agonist Syncria® (albiglutide) in men and women with type 2 diabetes.

The Phase III program will include more than 4,000 patients and will begin with five studies in early 2009. The objective of the program is to demonstrate durable efficacy and cardiovascular safety of albiglutide as mono- and add-on therapy. The primary efficacy endpoint for all studies will be the change from baseline in HbA1c compared to placebo and/or active comparators. A majority of the studies will include active comparators, including metformin, sulphonylurea, thiazolidinedione (TZD) insulin, and a dipeptidyl peptidase four inhibitor (DPP IV). The study duration is expected to be two to three years and the main dose and regimen for the programme will be 30 mg weekly.

Albiglutide is an investigational biological, injectable form of human GLP-1–a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced.

Albiglutide is the only medication that fuses human GLP-1 to human albumin. It is designed to have an extended duration of action and allow for weekly or less-frequent injections.

Source: PRNewswire 2/17/09

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