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New First in Class Diabetes Drug Shows Efficacy, Lower Risk for Hypoglycemia

Mar 8, 2012

A novel investigational drug called TAK-875 (Takeda), the first in its class to be tested in diabetes, provides glycemic control in patients with type 2 diabetes with less risk for hypoglycemia compared with standard treatment.

Charles Burant, MD, PhD, from the University of Michigan Medical School, Michigan, and colleagues, write, “TAK-875 targets the free fatty acid receptor (FFAR1), which results in increased insulin secretion when the receptor is activated in the presence of rising glucose levels.” “This study showed that treatment with TAK-875 for 12 weeks resulted in dose-dependent improvement in glycemic control of patients with type 2 diabetes who were not adequately treated with metformin or diet and exercise alone.” The authors also note that although the study was limited by its short duration, it provides new data showing that activation of FFAR1 receptors could be clinically useful in the treatment of diabetes.

In the phase 2 randomized, double-blind, placebo-controlled trial, 426 patients with type 2 diabetes were randomly assigned to receive 1 of 5 doses of TAK-875 (n = 303), glimepiride (n = 62), or placebo (n = 61). At 12 weeks, compared with placebo (18%), almost twice as many patients (range, 33% – 48%) receiving TAK-875 doses of 25 mg or higher achieved the American Diabetes Association target of glycosylated hemoglobin (HbA1c) levels less than 7%. The percentage of patients who achieved target HbA1c levels while receiving glimepiride (40%) was similar to the rate seen among patients taking TAK-875 doses of 25 mg or more.

The incidence of hypoglycemia was significantly lower in patients receiving TAK-875 (2%) than in those taking glimepiride (19%), and although there was no significant weight gain among patients receiving TAK-875 at 12 weeks when compared with baseline, glimepiride produced significant weight gain (0.86 kg; P = .004).

Experts have their doubts that TAK-875 could be a real alternative to currently used type 2 diabetes treatments.

Alan Garber, MD, PhD, professor of medicine, biochemistry, and cell biology at the Baylor College of Medicine in Houston, Texas, stated that, “The drug in this study is the first in its class to be tested in diabetes. It has a mechanism of action somewhat similar to the incretins.” “This is an interesting proof-of-concept study, but the drug used in this research is a new class of agents, so we need to have a little more data to be able to assess its efficacy and possible adverse events.”

One of the limitations of the study was the use of glimepiride as the comparator treatment as this medication has fallen out of favor with physicians who treat type 2 diabetes. The reason is its known adverse effects, including hypoglycemia and weight gain.

Published online February 27, 2012 in The Lancet