Diabetes Drug Doesn't Overdo Its Job

TAK875 for type 2 diabetes improves blood sugar control without higher risk of hypoglycemia

(RxWiki News) In the battle against diabetes, diet and exercise are our strongest weapons. When those fail, we often turn to drug treatment. So, it is good news when a new diabetes drug seems to be safer than those before it.

A new drug for type 2 diabetes called TAK-875 is just as effective as Amaryl (glimepiride) while having a much lower risk of causing hypoglycemia, a condition in which blood sugar levels become dangerously low.

"Ask your doctor about new diabetes treatments."

In a recent study, Charles Burant, M.D., Ph.D., of the University of Michigan Health System, and colleagues compared the effects of TAK-875 to those of placebo or glimepiride, a common diabetes treatment sold under the brand name Amaryl.

Type 2 diabetes happens when the body no longer responds to insulin, a hormone that controls blood sugar levels. Without a response to insulin, blood sugar levels can get dangerously high, which can lead to chronic conditions such as type 2 diabetes.

TAK-875 works by increasing the body's production of insulin when it is needed. That is, the drug has no impact on insulin production when blood sugar levels are normal. This characteristic reduces the risk of causing dangerous drops in blood sugar levels.

In more technical terms, TAK-875 activates a receptor called FFAR1, which plays a crucial role in triggering and controlling the production of insulin.

"In view of the frequent hypoglycemia after treatment with sulfonylureas,the low-risk of hypoglycaemia after treatment with TAK-875 suggests that there may be therapeutic advantage of targeting FFAR1 in treating people with type 2 diabetes," the authors say.

For their study, the researchers looked at 426 type 2 diabetes patients who were not getting good blood sugar control through diet, exercise, or metformin - the first line treatment for type 2 diabetes.

Dr. Burant and colleagues found that patients taking TAK-875 experienced large drops in levels of HbA1c (a measure of blood sugar levels over three months), compared to those taking placebo. Patients taking glimepiride had similar drops in HbA1c.

Patients taking TAK-875 were randomly assigned to one of five doses: 6.25 mg, 25 mg, 50 mg, 100 mg, or 200 mg.

When patients took TAK-875 doses of 25 mg or more, about twice as many participants reached the target blood sugar levels set by the American Diabetes Association.

In other words, 33 to 48 percent of patients taking TAK-875 doses of 25 mg or higher had an HbA1c of seven percent or less at the end of 12 weeks of treatment. A similar number of patients taking glimepiride (40 percent) achieved the target HbA1c.

In comparison, 19 percent of those taking placebo achieved that target.

The rate of side effects of treatment were similar for the TAK-875 patients and the placebo patients, with 49 percent of TAK-875 patients and 48 percent of placebo patients experiencing adverse events.

In contrast, 61 percent of participants in the glimepiride group experienced adverse events.

These differences are mainly due to the increased risk of hypoglycemia associated with glimepiride.

According to the study's authors, "TAK-875 significantly improved glycemic control in patients with type 2 diabetes with minimum risk of hypoglycemia. The results show that activation of FFAR1 is a viable therapeutic target for treatment of type 2 diabetes."

"We are truly 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," they conclude.

It should be noted that Dr. Burant is an unpaid consultant and advisor to Takeda Global Research and Development, a division of the company that discovered TAK-875.

The results of this phase 2 randomized trial appear in The Lancet