Clinical trial NCT01289119
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2010-12-01; Completion date: 2011-12-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Detailed description:
Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality.

Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia.

Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.

* Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
* Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
* Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

Arms: arm 1: Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. arm 2: Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. arm 3: Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. arm 4: Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. arm 5: Participants continued to receive their stable dose of pioglitazone with or without metformin, and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. arm 6: Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
Interventions: intervention 1: Alogliptin intervention 2: Placebo to alogliptin intervention 3: Metformin intervention 4: Pioglitazone
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Alogliptin placebo-matching tablets. intervention 3: Stable metformin dose intervention 4: Stable pioglitazone dose

Protocol documents: