A 24 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Trial of Once Daily Linagliptin, 5 Milligrams Orally, as Add on to Basal Insulin in Elderly Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 145
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
研究概览
简要总结
To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed.
In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 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
linagliptin 5 mg
patient to receive a tablet of linagliptin 5 mg each day
干预措施: linagliptin (Drug)
placebo
patient to receive a tablet of placebo matching linagliptin 5 mg
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
时间窗: Baseline and Week 24
This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
次要结局
- Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.(24 weeks)
- Percentage of Patients With HbA1c<8.0%(24 weeks)
- Percentage of Patients With HbA1c on Treatment <7.0%(24 weeks)
- Percentage of Patients With HbA1c Lowering by at Least 0.5%.(24 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline and Week 24)