JPRN-jRCT1080222203已完成Unknown
esina tablets special drug use surveillance: Type 2 diabetes mellitus: monotherapy/combination therapy with alpha-GI
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 3,317
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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