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

UMIN ID: UMIN000001393

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. Glimepiride will be administered orally 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 24 weeks (12 weeks screening period plus 12 weeks treatment period).
Each subject will orally receive SYR-322 25 mg once daily before breakfast. Glimepiride will be administered orally 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 24 weeks (12 weeks screening period plus 12 weeks treatment period).
Each subject will orally receive SYR-322 placebo once daily before breakfast. Glimepiride will be administered orally 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 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: Not applicable
• Gender: Male and Female
• Exclude criteria: The subject has taken other diabetic medications than sulfonylurea within 12 weeks before the initiation of the treatment period (Week 0).

Related Information

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