Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study

@article{Seino2011EfficacyAS,
  title={Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study},
  author={Yutaka Seino and Tetsuya Fujita and Shinzo Hiroi and Masashi Hirayama and Kohei Kaku},
  journal={Current Medical Research and Opinion},
  year={2011},
  volume={27},
  pages={1781 - 1792}
}
Abstract Objective: To compare the efficacy and safety of different dosages of alogliptin with that of placebo and voglibose in drug-naïve Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Research design and methods: In the double-blind, placebo-controlled phase of this two-part study, 480 patients aged ≥20 years with type 2 diabetes mellitus (HbA1c ≥6.9% to <10.4%) were randomized to monotherapy with alogliptin 6.25, 12.5, 25 or 50 mg once daily, placebo, or… 
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Primary efficacy was A1C change from baseline with the high-dose combination (A25 + P30) versus each monotherapy, and alogliptin is well tolerated drug.
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TLDR
The effect of the combination therapy on glycemic control was equal to that of alogliptin mono-therapy during a 3-month study period.
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