Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants 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.
Inclusion Criteria:

 1. Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the
 observation period (Week -12).

 2. Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or
 twice daily in the morning or in the morning and evening, before or after meal) for at
 least 12 weeks prior to the initiation of the treatment period (Week 0).

 3. Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after
 the initiation of the observation period (Week -4).

 4. 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).

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

 Exclusion Criteria:

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