DPP-4 Inhibitor Demonstrated Efficacy In Reducing Glucose Levels In Early Phase Study

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Alogliptin demonstrated efficacy in reducing glucose levels throughout the day, in an early phase clinical study.

Safety results for this multi-dose study showed that alogliptin was well tolerated in patients with type 2 diabetes, with an incidence of hypoglycemia similar to placebo. No serious adverse event was reported, and no dose-limiting toxicity was observed over the entire dose range of 25 to 400 mg. The data were announced during a poster presentation at the 67th Scientific Sessions of the American Diabetes Association (ADA) meeting in Chicago.

"These are encouraging early results for alogliptin as a potential new type 2 diabetes treatment to help manage glucose levels throughout the day," said Qais A. Mekki, MD, PhD, vice president, Clinical Science at Takeda Global Research & Development, Inc. "Alogliptin is a reflection of Takeda's commitment to finding innovative options to help patients manage their type 2 diabetes."

This was a randomized, double-blind, placebo-controlled, parallel-group, multi-dose study conducted in multiple centers. Subjects were patients with type 2 diabetes who were either newly diagnosed or treated with diet and exercise alone for the previous three months and were between the ages of 18 and 75 years.

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The objectives of the study were to assess the uptake, utilization and metabolism, as well as the tolerability, of alogliptin after multiple-dose administration to patients with type 2 diabetes. The primary efficacy endpoint was change in mean 4-hour postprandial plasma glucose levels from Baseline (Day -1) to Day 14. Secondary efficacy endpoints included change in mean 4-hour postprandial insulin levels; fasting plasma levels of C-peptide, fructosamine, and glycosylated hemoglobin (A1C); and incidence of hyperglycemia (blood glucose is greater than or equal to 200 mg/dL).

Fifty-five patients were assigned to receive alogliptin 25 (n=15), 100 (n=14), or 400 mg (n=15), or placebo (n=11) once daily for 14 days. Patients received three standardized meals a day and a snack after dosing on Days -1 (Baseline), 1 and 14. Blood and urine samples were collected through 24 hours after Day 1 and through 48 hours after Day 14.

On Day 14, statistically significant decreases from Baseline in mean 4-hour plasma glucose levels were observed for 25, 100, and 400 mg doses, after each of three meals. These reductions were compared to those achieved by placebo:

-- Breakfast: -39.9, -48.6, and -68.3 mg/dL, respectively

-- Lunch:

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