Major Finding: At 6 months, mean reduction in HbA1c 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 per 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: The study was funded by Biodel Corp., for which Dr. Rodbard serves on the advisory board. She also has consultant, speaker, and/or research grant support relationships with a number of other companies that make diabetes-related products.
ORLANDO — An investigational rapid-acting human insulin formulation provided glucose control similar to that of regular human insulin, but it yielded 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 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 at the scientific sessions 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 baseline, they had a mean hemoglobin A1c value of 8%. They were randomized to preprandial VIAject or human regular insulin in combination with previously prescribed insulin glargine, metformin, and/or thiazolidinedione therapy.
Because of the difference in action time, regular human insulin was injected 30-40 minutes before meals, while VIAject was given immediately before patients had meals.
At 6 months, the mean reduction in HbA1c was similar in the two groups: The VIAject group dropped by 0.56 percentage points, 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 per month, compared with 0.66 events per month with regular human insulin, Dr. Rodbard reported.
Patients who were taking VIAject also gained significantly less weight, an average of 0.46 kg vs. 1.35 kg in patients who were taking regular human insulin.
Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups, Dr. Rodbard reported.
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 is 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 on 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.