Long-term Tanzeum plus pioglitazone improved HbA1c in adults with type 2 diabetes

Adults with type 2 diabetes randomly assigned the once-weekly glucagon-like peptide-1 receptor agonist Tanzeum as an add-on to pioglitazone or pioglitazone plus metformin therapy saw a sustained improvement in HbA1c over 3 years vs. those assigned placebo, according to study findings presented at the 51st European Association for the Study of Diabetes Annual Meeting.

In a randomized, double blind, parallel-group analysis of patients participating in the Harmony 1 trial, researchers also found that fewer patients assigned Tanzeum (albiglutide, GlaxoSmithKline) required rescue therapy for hyperglycemia vs. those assigned placebo.

Christopher M. Perkins, MD, medical director for Pharmaceutical Product Development (PPD), and colleagues analyzed data from 310 adults with type 2 diabetes not controlled with pioglitazone ( 30 mg) or pioglitazone plus metformin therapy ( 1,500 mg; mean age, 55 years; 70% white, mean HbA1c, 8.1%; mean BMI, 34 kg/m²). Within the cohort, 80% of participants were assigned pioglitazone plus metformin therapy; average type 2 diabetes duration was 8 years.

Participants were randomly assigned 30 mg albiglutide once weekly (n = 150) or matching placebo (n = 149).

After 3 years of treatment, 59% of participants assigned albiglutide who did not require rescue therapy maintained an HbA1c of 7% or less vs. 46% of those assigned placebo; fasting plasma glucose results were similar.

“The new data shows that, along with the 1-year reduction in [HbA1c], there was durable response with albiglutide over time,” Perkins said during the presentation. “The HbA1c curve goes down rapidly at about 12 weeks, where we reach a maximum effect at this dose, and you can see up to week 156 that [HbA1c] is really the same, statistically speaking.”

When including participants who did receive hyperglycemic rescue therapy, results were similar, Perkins said. Body weight also remained stable during the 3-year period for those assigned albiglutide, including those who received rescue therapy.

Adverse events were similar between treatment groups; the most common were nausea, vomiting and diarrhea. Injection-site reactions were higher among participants assigned albiglutide (18% vs. 8.6%). Pre-rescue, documented symptomatic hyperglycemia was low, Perkins said (3.3% for albiglutide vs. 2% for placebo). – by Regina Schaffer

Reference:

Perkins, C, et al. Abstract 41. Presented at: 51st EASD Annual Meeting; Sept. 14-18, 2015; Stockholm.

Disclosure: Perkins reports being an employee and medical director of PPD.