Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily
 (QD) combined with a thiazolidine taken QD 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 pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment
 with pioglitazone as well as diet and exercise therapies.
Inclusion Criteria:

 1. Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16
 weeks prior to the start of the treatment period (Week 0).

 2. Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after
 the start of the observation period (Week -2).

 3. Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation
 period (Week -6) and 14 weeks after the start of the observation period (Week -2) from
 10 weeks after the start of the observation period (Week -6) (*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 a diabetic medications other than pioglitazone within 16 weeks before the
 start of the treatment period (Week 0).

 2. Had a history or symptoms of cardiac failure.