Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes
The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.
For patients diagnosed with type 2 diabetes mellitus, metformin is the usual first-line
therapy in addition to diet control and exercise. For those patients with inadequate glycemic
control with metformin monotherapy or experiencing serious side effects of metformin,
sulfonylurea is a popular choice as a second-line oral antidiabetic treatment.
Alogliptin is a dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use
in patients with type 2 diabetes mellitus.
This study is designed to further explore the durability of efficacy and safety of alogliptin
compared to glipizide in type 2 diabetes mellitus patients whose blood sugar level is
inadequately controlled with metformin therapy.
The duration of this study will be approximately 2 years.
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