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