Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,096
- 主要终点
- Number of Participants Reporting One or More Adverse Drug Reactions
研究概览
简要总结
To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy.
详细描述
This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and biguanides in participants with type 2 diabetes mellitus in the routine clinical setting.
Participants diagnosed with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy will be enrolled. The planned sample size is 1,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) 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
- •Participants who did not adequately respond to the following treatment • Treatment with biguanides in addition to diet therapy and exercise therapy
排除标准
- •Participants contraindicated for Nesina
- •Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus [these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate].
- •Participants with severe infection, pre- or post-operative patients, or patients with serious traumatic injury [blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate].
- •Participants with a history of hypersensitivity to any ingredient of Nesina.
结局指标
主要结局
Number of Participants Reporting One or More Adverse Drug Reactions
时间窗: Baseline up to 12 months
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. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
Number of Participants Reporting One or More Serious Adverse Drug Reactions
时间窗: Baseline up to 12 months
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
次要结局
- Change From Baseline in Fasting Blood Glucose(Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12))
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12))
- Percentage of Participants of Achieving Objective Glycemic Control(Baseline and final assessment (up to Month 12))
- Change From Baseline in Fasting Insulin Level(Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12))