Major Finding: At 6 months, mean reduction in hemoglobin A1c was similar between patients taking VIAject and those taking regular human insulin before meals but hypoglycemic event rates were significantly reduced with VIAject (0.33 vs. 0.66 events/month) and weight gain was significantly less with VIAject (0.46 vs. 1.35 kg).
Data Source: Open-label, multicenter, randomized phase III trial of 471 patients with type 2 diabetes
Disclosures: Biodel Corp. funded the study. Dr. Rodbard serves on the company's advisory board and has received research support from it. She also has consultant, speaker, and/or research grant support relationships with other companies that make diabetes-related products.
Orlando — An investigational rapid-acting human insulin formulation provided similar glucose control to regular human insulin but with a twofold reduction in hypoglycemia and significantly less weight gain in a 6-month, multicenter, open-label study of 471 patients with type 2 diabetes.
The insulin formulation, called VIAject, is absorbed more rapidly after subcutaneous injection than either insulin lispro or regular human insulin. Findings from Biodel Corp.'s phase III study of VIAject were presented by Dr. Helena Rodbard, an endocrinologist in private practice in Rockville, Md., and a past president of the American College of Endocrinology and the American Association of Clinical Endocrinologists.
The subjects had a mean age of 56 years, slightly more than half were male, and the mean body mass index was 33 kg/m
At 6 months, the mean reduction in hemoglobin A1c was similar in the two groups, with the VIAject group dropping by 0.56 percentage points and the regular human insulin group by 0.70 points. But nonsevere hypoglycemic event rates were significantly reduced in the patients taking VIAject, at just 0.33 events/month, compared with 0.66 events/month with regular human insulin, Dr. Rodbard reported.
Patients taking VIAject also gained significantly less weight, an average of 0.46 kg vs. 1.35 kg with regular human insulin.
Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups. Injection site pain or irritation was greater with VIAject, but this declined during the course of the study. Moreover, the proposed U-100 pH-neutral commercial formulation of VIAject is associated with less injection site discomfort than the U-25 pH 4 version used in this study, she pointed out.
Biodel is seeking Food and Drug Administration clearance to market VIAject based on two pivotal 6-month phase III clinical trials in patients with type 1 and type 2 diabetes, as well as results from long-term, 18-month safety extension trials for patients who completed the two pivotal phase III clinical trials. The Prescription Drug User Fee Act action date for Biodel's new drug application is expected to be Oct. 30, 2010, the company said in a statement.