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

Phase 2
Conditions
Type 2 diabetes mellitus.
Registration Number
JPRN-jRCT2080220568
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 stable dosage regimen of pioglitazone for at least 16 weeks prior to the initiation of the treatment period (Week 0)
- The subject has an HbA1c value of 6.5% or more and below 10.0% at 14 weeks after the initiation of the screening period (Week -2)
Key Criteria for exclusion:
- The subject has taken any antidiabetic medications except pioglitazone within the last 16 weeks prior to the initiation of the treatment period (Week 0)
- The subject with a history or symptoms of heart failure

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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