NCT01224366已完成3 期
A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 448
- 试验地点
- 6
- 主要终点
- HbA1c reduction
研究概览
简要总结
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of T2DM
- •On a stable dose of insulin as defined by the protocol
- •On a stable does of metformin (if applicable) as defined by the protocol
- •Age 18 to 80 years
- •HbA1c of 7.5 to 11.0%
- •Body Mass Index (BMI) 22 to 40 kg/m2
排除标准
- •Type 1 diabetes
- •Short-acting or rapid-acting insulin
- •Pregnancy or lactation
- •Evidence of serious diabetic complications
- •Evidence of serious cardiovascular complications
- •Laboratory value abnormalities as defined by the protocol
- •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
HbA1c reduction
时间窗: 24 weeks
次要结局
- Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)(24 weeks)
- Responder rates (overall and subpopulations)(24 weeks)
- HbA1c reduction in subpopulation treated with insulin and with metformin(24 weeks)
- HbA1c reduction in subpopulation treated with insulin and without metformin(24 weeks)
- Reduction in FPG (overall and subpopulations)(24 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00351884Novartis Pharmaceuticals370
已完成
2 期
Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00821977Novartis338
已完成
2 期
Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00860288Novartis Pharmaceuticals1,988
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
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)NCT00337610Merck Sharp & Dohme LLC190