esina tablets special drug use surveillance Type 2 diabetes mellitus: Combination therapy with sulfonylurea
Not Applicable
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080222219
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Patients who did not adequately respond to the following treatment
•Treatment with sulfonylurea in addition to diet therapy and exercise therapy
Exclusion Criteria
Patients contraindicated for Nesina
(1) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus [these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.]
(2) Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury [blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.]
(3) Patients with a history of hypersensitivity to any ingredient of Nesina
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event (adverse reactions), HbA1c<br>Frequency of adverse events (adverse reactions), HbA1c time profile<br>Primary timeframe 12 months
- Secondary Outcome Measures
Name Time Method Fasting blood glucose<br>Changes in fasting blood glucose<br>Secondary timeframe 12 months