JPRN-jRCT1080222558已完成Unknown
esina Tablets specified drug-use survey Type 2 diabetes mellitus: Combination therapy with hypoglycemic drug (insulin preparation or rapid-acting insulin secretagogues, etc)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 964
研究概览
简要总结
This survey was conducted to evaluate the safety and efficacy of long-term use of Nesina in patients with type 2 diabetes mellitus who had had inadequate response to hypoglycemic agents such as insulin or rapid-acting insulin secretagogues in addition to dietary/exercise therapy. The survey results raised no major concerns about the safety or efficacy of long-term use of Nesina.
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
- •Type 2 diabetic patients meeting the following criteria are included in this survey:
- •Patients who have had an inadequate response to the following medications/therapies:
- •-Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues (RAIS), excluding other types of hypoglycemic agents (e.g., alpha-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise therapy
- •* For use of Nesina Tablets in combination with these agents, a specified drug-use survey is currently ongoing.
排除标准
- •Type 2 diabetic patients who meet any of the following criteria are excluded from this survey:
- •Patients with contraindications for Nesina Tablets
- •(1) Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus [Quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of Nesina Tablets is not appropriate.]
- •(2) Those with severe infections, before or after surgery, or with serious trauma [Controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of Nesina Tablets is not appropriate.]
- •(3) Those with a history of hypersensitivity to any of the ingredients of Nesina Tablets
研究者
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