March 1, 2012

GPR40 may be on par for treating Type 2 diabetes

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Takeda has a new drug to treat type 2 diabetes that is blood glucose dependent. This could be the next generation of safer, more effective treatments to help mitigate the epidemic of type 2 diabetes.

The newest contender, cleverly named TAK-875, is the  first treatment of this kind for type 2 diabetes. It targets GPR40, which activates insulin secretion based on free fatty acids in the blood . It may be beneficial in the treatment of type 2 diabetes, without significantly increasing the risk of hypoglycemia.

In a Phase 2 stuy, participants were divided into groups receiving  TAK-875 (1 of 5 doses), glimepiride, or placebo. At the end of the 12 week study, patients taking TAK-875 in doses of 25 mg or higher did as well, or better, than the patients taking glimepiride. Furthermore the incidence of hypoglycemia was noteworthy among patients taking TAK-875 (2%) compared to those taking glimepiride (19%). There was no significant weight gain among patients taking TAK-875 when compared with patients taking glimepiride, who produced significant weight gain.

The rate of medication-related adverse side effects from TAK-875 was similar to the placebo and significantly lower than the glimepiride groups.

So far, so good – right? Doctors are still holding their breath on the opportunity cost for the efficacy of the new class of drug. Throughout the trial, 3 patients takingTAK-875 had serious adverse events that led to discontinuation, including liver function test abnormalities, cardiac arrest with kidney failure, and coronary artery disease and carotid artery stenosis.

There is voice of reason sounding from Dr. Preethi Srikanthan, an associate professor of medicine at the University of California, Los Angeles.  “The results of the study, with some improvement in 3-month blood sugar values and with less hypoglycemia, are interesting, but as the authors point out, they are merely ‘hypothesis-generating. The doctor adds, “It’s also ominous that even at this early stage, there were several cardiovascular events in patients on TAK-875, and 2 patients who developed kidney and liver function test abnormalities”.

Clearly Dr. Srikanthan is not a paid spokesperson for Takeda because she continued to explain why the trial may have been a little unfair. The choice to use glimepiride was almost unreasonable considering it is not the “gold standard” for type 2 diabetes drug treatment. They are known to have adverse side effects such as hypoglycemia and weight gain.  

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