Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,198
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had One or More Adverse Events
研究概览
简要总结
The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.
详细描述
The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.
This multi-center observational trial will be conducted in Japan.
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 diabetes mellitus patients
排除标准
- •Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
- •Have severe infection, perioperative status, or serious trauma
- •Have severe renal impairment or on dialysis due to end-stage renal disease
- •Have a history of hypersensitivity to any ingredients of this drug
研究组 & 干预措施
Trelagliptin 100 mg
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
干预措施: Trelagliptin (Drug)
结局指标
主要结局
Number of Participants Who Had One or More Adverse Events
时间窗: 36 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants Who Had One or More Adverse Drug Reactions
时间窗: 36 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
次要结局
- Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)(Baseline, up to final assessment point (up to Month 36))
- Change From Baseline in Fasting Blood Glucose(Baseline, up to final assessment point (up to Month 36))
- Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)(Baseline, up to final assessment point (up to Month 36))
- Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)(Baseline, up to final assessment point (up to Month 36))
- Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)(Baseline, up to final assessment point (up to Month 36))
- Change From Baseline in Fasting Insulin Level(Baseline, up to final assessment point (up to Month 36))
- Change From Baseline in Fasting Glucagon(Baseline, up to final assessment point (up to Month 36))
- Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)(Baseline, up to final assessment point (up to Month 36))