Nesina Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,374
- 主要终点
- Number of Participants Reporting One or More Adverse Drug Reactions
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones 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 thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting.
Participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. The planned sample size is 1,000 subjects.
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
- •Patients who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy
排除标准
- •Patients contraindicated for Nesina
- •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.)
- •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.)
- •Patients with a history of hypersensitivity to any ingredient of Nesina
研究组 & 干预措施
Alogilptin 25mg, tablets, orally, once daily, up to 12 months
干预措施: Alogliptin (Drug)
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 + thiazolidinedione 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 + thiazolidinedione and alogliptin + other arm separately.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months))
- Percentage of Participants of Achieving Objective Glycemic Control(Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months))
- Change From Baseline in Fasting Blood Glucose(Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months))
- Change From Baseline in Fasting Insulin(Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months))