Weekly biologic enters phase III trials

June 8, 2009

The investigational biologic injectable human GLP-1-a peptide albiglutide reduced hemoglobin A1c (HbA1c) and was associated with weight loss when administered weekly, biweekly, or monthly, reports Julio Rosenstock, MD, Dallas Diabetes and Endocrine Center at Medical City, TX.

The investigational biologic injectable human GLP-1-a peptide albiglutide reducedhemoglobin A1c (HbA1c) and was associated with weight losswhen administered weekly, biweekly, or monthly, reports Julio Rosenstock, MD, DallasDiabetes and Endocrine Center at Medical City, TX.

A phase II trial included 356 patients with type 2 diabetes previously treatedwith diet and exercise or metformin but who still had mean baseline HbA1clevels of 8.9%. The average duration of type 2 diabetes was five years, mean age was53 years, and mean baseline body mass index was 32 kg/m². Patients wererandomized to receive placebo; exenatide; weekly albiglutide of 4 mg, 15 mg, or 30mg doses; biweekly albiglutide of 15 mg, 30 mg, or 50 mg doses; or monthlyalbiglutide of 50 mg or 100 mg doses. All patients were treated for a total of 16weeks.

After 16 weeks of treatment, HbA1c levels were reduced by 0.9%, 0.8%,and 0.9% in the albiglutide weekly, biweekly, and monthly groups, respectively. Patients taking exenatide had a 0.5% reduction in HbA1c, and patients taking placebo hada 0.17% reduction. Statistically significant reductions in HbA1c versusplacebo occurred in the 30 mg weekly, 30 mg and 50 mg biweekly, and 100 mg monthlyalbiglutide groups, Dr. Rosenstock reports.

Weight loss occurred in all albiglutide treatment groups and ranged from 0.9 kgto 1.8 kg.

There was no documented hypoglycemia incidence during the study related toalbiglutide treatment, and the most frequent adverse events were nausea, vomiting,and headache, which occurred in less than 10% of patients at the 30 mg weekly doseand subsided after the first 8 weeks of treatment, Dr. Rosenstock says. Positiveanti-ALB antibodies were detected in 2.5% of patients, including one patient in theplacebo group.

“While these results need to be confirmed in ongoing studies, the findings withalbiglutide are important,” says Dr. Rosenstock.

Five phase III clinical trials with albiglutide 30 mg weekly have beeninitiated.