Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Sulfonylurea in Subjects With Type 2 Diabetes in Japan
The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.
Both insulin hyposecretion and insulin-resistance are considered to be involved in the
development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in
patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl
peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the
degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected
that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on
to sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite
treatment with an sulfonylurea as well as diet and exercise therapies.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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