Diabetes patients now have an experimental drug that improves blood sugar control without increasing the risk of low blood sugar (hypoglycemia) in patients with type 2, 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 involves a gradual decline in how insulin responds to changes in blood sugar (glucose).
The new drug, alled 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.