Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD)
 combined with metformin taken twice daily (BID) or three times daily (TID) 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 metformin in type 2 diabetic patients who have uncontrolled blood glucose despite
 treatment with metformin as well as diet and exercise therapies.
Inclusion Criteria:

 1. Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal
 or 750 mg/day three times daily after meal) for at least 12 weeks prior to the
 initiation of the treatment period (Week 0).

 2. Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks
 after the initiation of the observation period (Week -4).

 3. Had an HbA1c difference between 4 weeks after the initiation of the observation period
 (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being
 within 10.0%* of the value at 4 weeks after the initiation of the observation period
 (Week -8) (*rounded off to the first decimal place).

 4. Was receiving specific diet and exercise (if any) therapies during the observation
 period.

 Exclusion Criteria:

 1. Had taken other diabetic medications than metformin within 12 weeks before the
 initiation of the treatment period (Week 0).

 2. With a history or symptoms of lactic acidosis.