NCT00396227已完成3 期
A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.
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
- 2,665
- 试验地点
- 1
- 主要终点
- Change from baseline in HemoglobinA1c (HbA1c)
研究概览
简要总结
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
- •Agreement to maintain the same dose of metformin from screening to the end of the study
- •Age in the range of 18-80 years
- •Body mass index (BMI) in the range of 22-40 kg/m2
- •HbA1c in the range of 7.0 to 10%
- •FPG <270 mg/dL (15 mmol/L)
排除标准
- •A history of type 1 diabetes
- •Liver disease
- •Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Vildagliptin 100mg + Met
干预措施: vildagliptin (Drug)
TZD
Active Comparator
TZD + metformin
干预措施: thiazolidinedione (TZD) (Drug)
结局指标
主要结局
Change from baseline in HemoglobinA1c (HbA1c)
时间窗: after 12 weeks of treatment
次要结局
- Change from baseline in body weight(after 12 weeks of treatment)
- Change from baseline in fasting plasma glucose (FPG)(after 12 weeks of treatment)
- Incidence of prespecified adverse events while on treatment with study drug(12 week treatment duration)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00382096Novartis Pharmaceuticals1,179
已完成
3 期
To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00368134Novartis370
已完成
2 期
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell CarcinomaBasal Cell CarcinomaNCT01367665Hoffmann-La Roche1,232
已完成
2 期
Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00115193Amgen77
招募中
不适用
Access Cannulation Trial IIVascular Access ComplicationComplications DialysisNCT05490225Voyager Biomedical100