Alogliptin tablets special drug use surveillance Type 2 diabetes mellitus: monotherapy/combination therapy with alpha-GI
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080222203
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
This survey was conducted to investigate the safety and efficacy of long-term use of Nesina in patients with inadequately controlled type 2 diabetes mellitus on diet and exercise therapies either alone or plus an alpha-GI. The survey results raised no major concerns about the safety or efficacy of long-term Nesina therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 3317
Patients who have not adequately responded to any one of the following therapies:
(1) Diet and exercise therapy alone
(2) In addition to diet and exercise therapy, use of alpha-glucosidase inhibitor
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
- Secondary Outcome Measures
Name Time Method