Double-blind comparative study of SYR-322-MET
Phase 3
- Conditions
- Type 2 Diabetes mellitus
- Registration Number
- JPRN-jRCT2080222327
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 374
Inclusion Criteria
1. The subject is an outpatient.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
etc.
Exclusion Criteria
1. The subject has any serious cardiac disease, any serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c<br>Primary timeframe Baseline and Week 24<br><br>Measurement of change from baseline in HbA1c
- Secondary Outcome Measures
Name Time Method 1. HbA1c, fasting blood glucose<br>2. Adverse events<br>Secondary timeframe Baseline and Week 24<br>1. HbA1c and fasting blood glucose<br>Measurement of HbA1c and fasting blood glucose<br>2. Adverse events<br>Number of cases with adverse events