A Phase 2/3 Study of SYR-322 as an Add-on to a Metformi
Phase 2
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT2080220606
- 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 metformin 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 6.5% 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 metformin within 12 weeks before the initiation of the treatment period (Week 0).
The subject with a history or symptoms of lactic acidosis.
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