Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 312
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Alogliptin and glimepiride intervention 2: Alogliptin and glimepiride intervention 3: Glimepiride
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 3: Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.

Protocol document: