NCT00860288已完成2 期
Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,988
- 试验地点
- 183
- 主要终点
- To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment
研究概览
简要总结
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-78 years old inclusive at Visit 1
- •T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
- •Patient agreement to maintain same dose of metformin throughout study
- •HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
- •Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1
排除标准
- •Pregnant or nursing (lactating) women
- •FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Metformin (Drug)
Vildagliptin Dose 1
Experimental
干预措施: Vildagliptin (Drug)
Vildagliptin Dose 1
Experimental
干预措施: Metformin (Drug)
Vildagliptin Dose 2
Experimental
干预措施: Vildagliptin (Drug)
Vildagliptin Dose 2
Experimental
干预措施: Metformin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Sitagliptin
Active Comparator
干预措施: Metformin (Drug)
Sitagliptin
Active Comparator
干预措施: Sitagliptin (Drug)
结局指标
主要结局
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment
时间窗: 24 weeks
次要结局
- To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin.(24 weeks)
- To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.(24 weeks)
- To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.(76 weeks)
- To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment.(24 weeks)
- To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment.(24 weeks)
- To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.(24 weeks)
- To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.(76 weeks)
研究者
研究点 (183)
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