Experimental Drug Shows Promise Against Type 2 Diabetes

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 metformin.

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 The Lancet.

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 glimepiride.

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 anti-diabetic agents.”

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.”

More information

The U.S. National Institute of Diabetes and Digestive and Kidney
Diseases has more about diabetes medicines.

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