A study, published online in the journal Current Medical Research and Opinion, showed that a greater percentage of patients with type 2 diabetes treated with the fixed-dose combination ACTOplus met® (pioglitazone HCl and metformin HCl) as initial therapy reached the study goal of hemoglobin A1c (HbA1c) of less than or equal to 7 percent compared to either component alone. Safety and tolerability of ACTOplus met therapy were evaluated by rate of drug discontinuation and treatment-emergent adverse events.
"Diabetes is a progressive and chronic condition, which requires continued monitoring by a patient and physician. In addition to diet and exercise, patients often need to take multiple medications to help them manage their glucose control," said Robert Spanheimer, M.D., vice president of medical and scientific affairs, Takeda Pharmaceuticals North America, Inc. "We are pleased to see that this study was successful in meeting its intended endpoints. A greater number of patients reached the blood sugar target of less than 7 percent, as recommended by the American Diabetes Association, using combination therapy as initial treatment compared with either single treatment alone."
Upon completion of the study, all treatment groups achieved statistically significant HbA1c reductions (p<0.001) from a baseline HbA1c of 8.7, and the greatest decrease was observed in patients treated with ACTOplus met (15 mg/850 mg twice daily) (-1.83 percent versus 0.99 percent and 0.96 percent with ACTOS® (pioglitazone HCl) (15 mg twice daily) or metformin (850 mg twice daily), respectively). The endpoint responder rates were higher in the ACTOplus met group, with 64 percent of patients reaching HbA1c goal of less than or equal to 7 percent compared to ACTOS (46 percent) or metformin (39 percent) alone.
The overall treatment-emergent adverse events were 50.7 percent for the ACTOplus met group; 52.1 percent for the ACTOS group; and 53.1 percent for the metformin group. These adverse events led to discontinuation from the study in 5.5 percent, 7.9 percent, and 7.2 percent of patients, respectively. Adverse events that occurred more frequently in the ACTOplus met group with an incidence of greater than or equal to 3 percent included: headache at 5.5 percent, pharyngitis and nasopharyngitis each at 4 percent, and dizziness and insomnia each at 3 percent. The hypoglycemic event rates were 1.0 percent for the ACTOplus met group; 0.5 percent for the ACTOS group; and 1.4 percent for the metformin group. There was change in weight from baseline in all groups: 0.69kg in the ACTOplus met group, 1.64kg in the ACTOS group, and -1.28kg in the metformin group.
The secondary endpoints of the study included change from baseline in fasting plasma glucose (FPG), fasting insulin and homeostatic model assessment-insulin resistance (HOMA-IR), a method used to measure insulin resistance. The study showed significantly greater FPG lowering in the ACTOplus met group (p<0.01) compared with ACTOS monotherapy or metformin monotherapy; and statistically significant reductions in insulin resistance were observed following treatment with ACTOplus met compared to metformin.
SOURCE Takeda Pharmaceuticals North America