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

FDA Approves New Type 2 Diabetes Drug Tanzeum (albiglutide).

Millions of Americans with type 2 diabetes have a new treatment option with the U.S. Food and Drug Administration’s approval Tuesday of a once-weekly injectable drug, Tanzeum.

The FDA described Tanzeum (albiglutide) as a “glucagon-like peptide-1 (GLP-1) receptor agonist — a hormone that helps normalize patients’ blood sugar levels.

Tanzeum “can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes,” Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in an agency news release.

The FDA’s approval of the drug was based on eight clinical trials that included more than 2,000 people with type 2 diabetes. Those who took Tanzeum showed improvements in blood sugar control. The drug has also been studied for use in combination with other diabetes medications such as metformin, glimepiride, pioglitazone (Actos) and insulin.

The most common side effects seen with Tanzeum were nausea and/or reactions at the site of injection, the FDA said.

The drug, which is manufactured by GlaxoSmithKline, is not approved to treat Type 1 diabetes, the FDA noted.

The drug will carry a boxed warning stating that the use of some GLP-1 receptor agonists have been associated with thyroid tumors in rodents. The FDA said Tanzeum should not be prescribed for patients with a personal or family history of a type of thyroid cancer called medullary thyroid carcinoma (MTC), or for patients with Multiple Endocrine Neoplasia syndrome type 2. Patients with this disease have tumors in more than one gland in their body and are at increased risk for MTC.

Dr. Spyros Mezitis is an endocrinologist at Lenox Hill Hospital in New York City. He said Tanzeum joins a list of other approved injectable diabetes medicines, including Victoza (liraglutide), Byetta (exenatide) and Bydureon (exenatide extended release).

“Post-marketing clinical trials are planned to examine cardiovascular effects, use in pediatric patients, and possible increase in pancreatitis or medullary thyroid cancer,” Mezitis said. “The results of these clinical trials will determine which GLP-1 agonists will be more useful” to patients.

According to the FDA, about 24 million people in the United States have type 2 diabetes, which accounts for more than 90 percent of all diabetes cases diagnosed in the United States. Over time, the high blood sugar levels produced by diabetes can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.