A Phase 2/3 Study of SYR-322 as an Add-on to a Sulfonylurea
Phase 2
- Conditions
- Type 2 diabetes mellitus.
- Registration Number
- JPRN-jRCT2080220603
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Key Criteria for inclusion:
The subject has been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period.
The subject has been taking sulfonylurea at a stable dose regimen for at least 12 weeks prior to the initiation of the treatment period(Week 0).
The subject has an HbA1C of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period(Week -4).
Exclusion Criteria
Key Criteria for exclusion:
The subject has taken other diabetic medications than sulfonylurea within 12 weeks before the initiation of the treatment period (Week 0).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c change at the completion of treatment from baseline
- Secondary Outcome Measures
Name Time Method