An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 574
- 试验地点
- 43
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bigu+Lina
biguanide plus linagliptin
干预措施: Linagliptin (Drug)
Glin+Lina
glinide plus linagliptin
干预措施: Linagliptin (Drug)
Glit+Lina
glitazone plus linagliptin
干预措施: Linagliptin (Drug)
SU+Lina
sulfonylurea plus linagliptin
干预措施: Linagliptin (Drug)
A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
干预措施: Linagliptin (Drug)
SU+Met
sulfonylurea plus metformin
干预措施: Metformin (Drug)
A-GI+Met
alpha-glucosidase inhibitor plus metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: The first drug administration through 7 days after the last drug administration, up to 382 days
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
次要结局
- Glycosylated Haemoglobin A1c (HbA1c)(Baseline and 52 weeks)