Phase 3 Results for Alogliptin Demonstrated Significant Blood Sugar Reductions in Monotherapy and Four Add-on Thera...(igher baseline HbA1c. Safety results sho...),Health

"Alogliptin is another example of Takeda's commitment to advance the science of diabetes," said David Recker, M.D., senior vice president, Clinical Sciences, at Takeda. "The addition of alogliptin to the Takeda diabetes franchise would potentially enable us to address two of the core defects associated with type 2 diabetes, insulin deficiency and insulin resistance, ultimately helping patients improve their overall blood glucose control."

Alogliptin Phase 3 Study Results

In all five studies, at study end (week 26), mean change from baseline HbA1c levels were significantly greater, (P<.001), for both 12.5 mg and 25 mg alogliptin doses versus placebo, respectively:
-- alogliptin monotherapy: -0.56 percent, -0.59 percent, -0.02 percent

-- metformin add-on: -0.60 percent, -0.60 percent, -0.1 percent

-- thiazolidinediones add-on: -0.66 percent, -0.80 percent, -0.19 percent

-- insulin add-on: -0.63 percent, -0.71 percent, -0.13 percent

-- sulfonylurea add-on: -0.38 percent, -0.52 percent, +0.01 percent

A greater percentage of patients achieved HbA1c levels of less than or equal to 7 percent at both 12.5 mg and 25 mg alogliptin doses versus placebo, respectively, in the following studies:
-- alogliptin monotherapy: 47 percent (P=.001), 44 percent (P=.008), 23

percent

-- metformin add-on: 52 percent (P<.001), 44 percent (P<.001), 18 percent

-- sulfonylurea add-on: 30 percent (P=.057), 35 percent (P=.002), 18

percent

In all five studies, at study end, mean changes from baseline HbA1c levels were similar regardless of age, BMI or ethnicity.

Alogliptin was well-tolerated at all doses and in combination with other type 2 diabetes medications. Common adverse events were similar ac
'/>"/>