NCT01257451已完成3 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents)
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
- 431
- 试验地点
- 1
- 主要终点
- To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo
研究概览
简要总结
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: ≥ 70 years inclusive at Visit
- •patients with a confirmed diagnosis of T2DM
- •HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
- •body mass index (BMI) in the range of 19-45kg/m2
排除标准
- •FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- •previous or current participation in any vildagliptin clinical study.
- •history of hypersensitivity to DPP-4 inhibitors.
- •concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- •donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Vildagliptin
Experimental
干预措施: Vildagliptin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo
时间窗: 24 weeks
次要结局
- To assess the responder rates of patients treated with vildagliptin as compared to placebo(24 weeks)
- To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram.(24 weeks)
- To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo(24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01497522Novartis Pharmaceuticals183
已完成
4 期
Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM PatientsType 2 Diabetes Mellitus (T2DM)NCT02002221Novartis Pharmaceuticals156
已完成
3 期
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin MonotherapyType 2 Diabetes MellitusNCT00822211Novartis404
已完成
3 期
Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT01582230Novartis Pharmaceuticals293
已完成
3 期
Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 DiabetesType 2 Diabetes MellitusNCT01357252Novartis Pharmaceuticals279