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

UMIN ID: UMIN000001382

Registered date:01/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 2007/11/01
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Each subject will orally receive SYR-322 12.5mg once daily before breakfast for 12 weeks. Pioglitazone will be administered as 15 mg or 30 mg once daily before breakfast for 28 weeks(16 weeks screening plus 12 weeks treatment).
Each subject will orally receive SYR-322 25mg once daily before breakfast for 12 weeks. Pioglitazone will be administered as 15 mg or 30 mg once daily before breakfast for 28 weeks(16 weeks screening plus 12 weeks treatment).
Each subject will orally receive placebo once daily before breakfast for 12 weeks. Pioglitazone will be administered as 15 mg or 30 mg once daily before breakfast for 28 weeks(16 weeks screening plus 12 weeks treatment).

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: 1)The subject has taken other diabetic medications than pioglitazone within 16 weeks before the initiation of the treatment period (Week 0) 2)The subject with a history or symptoms of cardiac failure

Related Information

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