A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin

UMIN ID: UMIN000001394

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 2008/08/01
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Each subject will orally receive SYR-322 12.5 mg once daily before breakfast. Metformin will be administered orally 500 mg/day, twice daily after meal, or 750 mg thrice daily after meal for 24 weeks (12 weeks screening period plus 12 weeks treatment period).
Each subject will orally receive SYR-322 25 mg once daily before breakfast. Metformin will be administered orally 500 mg/day, twice daily after meal, or 750 mg thrice daily after meal for 24 weeks (12 weeks screening period plus 12 weeks treatment period).
Each subject will orally receive SYR-322 placebo once daily before breakfast. Metformin will be administered orally 500 mg/day, twice daily after meal, or 750 mg thrice daily after meal for 24 weeks (12 weeks screening period plus 12 weeks treatment period).

Outcome(s)

• Primary Outcome: HbA1c change at the completion of treatment from baseline

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)The subject has taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0). 2)The subject with a history or symptoms of lactic acidosis.

Related Information

• Primary Sponsor: Takeda Pharmaceutical Company Limited
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited