Alogliptin (Nesina) Tablets Specified Drug-use Survey "Type 2 Diabetes Mellitus: Combination Therapy With Hypoglycemic Drug (Insulin Preparation or Rapid-acting Insulin Secretagogues, Etc)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 964
- 主要终点
- Percentage of Participants Who Had One or More Adverse Reactions
研究概览
简要总结
The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.
* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.
详细描述
This survey was designed to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.
For adults, 25 mg of alogliptin is usually administered orally once daily.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
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, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise therapy
- •* For use of alogliptin 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 alogliptin tablets
- •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 alogliptin tablets is not appropriate.]
- •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 alogliptin tablets is not appropriate.]
- •Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets
研究组 & 干预措施
Alogliptin
Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.
干预措施: Alogliptin (Drug)
结局指标
主要结局
Percentage of Participants Who Had One or More Adverse Reactions
时间窗: Up to Month 12
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
次要结局
- Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])(Baseline, and final assessment point (up to Month 12))
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, and final assessment point (up to Month 12))
- Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])(Baseline, and final assessment point (up to Month 12))
- Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)(Baseline, and final assessment point (up to Month 12))
- Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)(Baseline, and final assessment point (up to Month 12))
- Change From Baseline in Laboratory Test Values (Fasting Insulin Level)(Baseline, and final assessment point (up to Month 12))