Experimental Drug Shows Promise Against Type 2
SUNDAY, Feb. 26 (HealthDay News) -- An experimental drug
improves patients' blood sugar control without increasing the risk
of low blood sugar (hypoglycemia) in patients with type 2 diabetes,
according to the results of a phase 2 clinical trial.
Type 2 diabetes is the more prevalent form of the disease,
accounting for about 90 percent of cases. Often tied to obesity,
type 2 diabetes involves a gradual decline in how insulin responds
to changes in blood sugar (glucose).
The new drug, called TAK-875, is a pill designed to enhance the
secretion of insulin in response to such changes, which means that
it has no effect on insulin secretion when blood sugar levels are
normal -- potentially reducing the risk for hypoglycemia.
The trial, led by Dr. Charles Burant of the University of
Michigan Medical School, included 426 patients with type 2 diabetes
who were not getting adequate blood sugar control through diet,
exercise or treatment with the first-line diabetes drug
The patients were randomly assigned to receive either TAK-875
(303 patients), placebo (61 patients), or another diabetes drug
called glimepiride (brand named Amaryl).
The study was funded by Takeda Pharmaceutical (which is
developing the drug), and appears online Feb. 26 in
After 12 weeks, all the patients taking the different doses of
TAK-875 had significant drops in their blood sugar levels, the
researchers said. A similar reduction occurred in patients taking
However, the incidence of episodes of hypoglycemia was much
lower among patients taking TAK-875 (2 percent) than among those
taking glimepiride (19 percent) and the same as those taking the
placebo (2 percent).
The incidence of treatment-related side effects was 49 percent
among patients taking TAK-875, 48 percent among those in the
placebo group, and 61 percent among those in the glimepiride group,
according to the researchers. They write that they are "excited
about the potential of TAK-875 and are eager to conduct larger
trials to find out how well this drug works, how safe it is and
what its place is in the treatment of diabetes."
In a journal commentary, Clifford Bailey of Aston University in
Birmingham, England, cautioned that, "on the journey to approval of
a new class of treatment for type 2 diabetes, many questions will
be asked of [drugs such as TAK-875]," including questions of how
long they might remain effective, as well as safety issues.
Other diabetes experts had mixed views on the new findings.
Dr. Loren Wissner Greene is clinical associate professor of
endocrinology at NYU Langone Medical Center in New York City. She
noted that glitazones -- a separate class of newer drugs such as
Rezulin, Avandia and Actos that also target insulin resistance --
have all shown initial promise in clinical trials before worrisome
side effects began to surface in users (Avandia was recently
withdrawn from the U.S. market due to heart risks).
As for TAK-875, it targets a separate mechanism "but again,
until more is known about short-term and long-term cardiovascular
effects, we need to proceed with moderated enthusiasm for each new
drug and drug mechanism," Wissner Greene said.
Dr. Minisha Sood, endocrinologist at Lenox Hill Hospital in New
York City stressed that, "given the rising global incidence of type
2 diabetes, the medical community is eagerly awaiting the
development of novel agents to add to our existing armamentarium of
She said that, "though this study includes a small sample size
followed for a short period of time, the results are promising in
that TAK-875 appears to be effective for glycemic [blood sugar]
control without significant risk for hypoglycemia or weight gain.
However, like Wissner-Greene, Sood said that "further investigation
is warranted, especially including [heart disease] patients."
The U.S. National Institute of Diabetes and Digestive and Kidney
Diseases has more about
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