NCT01214239已完成3 期
A Randomized, db, Placebo Controlled Parallel Group Efficacy and Safety Study Over 24 Weeks in T2D Patients in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 19
- 主要终点
- HbA1c Change From Baseline at Week 24
研究概览
简要总结
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment in monotherapy in patients with type 2 diabetes and insufficient 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
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
Experimental
once a day
干预措施: Linagliptin (Drug)
Placebo
Placebo Comparator
once a day
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c Change From Baseline at Week 24
时间窗: Baseline and at week 24
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
次要结局
- HbA1c Change From Baseline at Week 6(Baseline and at week 6)
- HbA1c Change From Baseline at Week 18(Baseline and at week 18)
- FPG Change From Baseline at Week 18(Baseline and at week 18)
- FPG Change From Baseline at Week 24(Baseline and at week 24)
- Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.(baseline and at week 24)
- FPG Change From Baseline at Week 6(Baseline and at week 6)
- FPG Change From Baseline at Week 12(Baseline and at week 12)
- Number of Patients With HbA1c < 7.0%(baseline and at week 24)
- Number of Patients With HbA1c < 6.5%(baseline and at week 24)
- Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.(baseline and at week 24)
- Number With HbA1c at Least Lowering 0.5%(baseline and at week 24)
- HbA1c Change From Baseline at Week 12(Baseline and at week 12)
- HbA1c Change From Baseline at Week 24 in the Subset of Chinese Patients(Baseline and at week 24)
研究者
研究点 (19)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin TherapyDiabetes Mellitus, Type 2NCT01215097Boehringer Ingelheim306
终止
2 期
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03517566Novartis Pharmaceuticals293
已完成
2 期
A Trial Investigating the Effect of 4 Weeks Dosing of XEN-D0501 on Blood Glucose Reduction in Patients With DiabetesEfficacySafetyPharmacokineticsDiabetes Mellitus, Type 2NCT05353686Pila Pharma54
已完成
3 期
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in KoreanAcute MigraineNCT04218162IlDong Pharmaceutical Co Ltd294
已完成
2 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced ConstipationOpioid Induced ConstipationNCT01459926Glycyx Therapeutics217