NCT00821977已完成2 期
Efficacy and Long-Term Safety of Vildagliptin as Monotherapy 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
- 发起方
- Novartis
- 入组人数
- 338
- 试验地点
- 170
- 主要终点
- Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks.
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 monotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years of age at Visit 1
- •Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
- •HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
- •Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1
排除标准
- •Pregnant or lactating female
- •FPG ≥ 270 mg/dL (≥15 mmol/L)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Vildagliptin Dose 1
Experimental
干预措施: Vildagliptin (Drug)
Vildagliptin Dose 2
Experimental
干预措施: Vildagliptin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks.
时间窗: 24 weeks
次要结局
- Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks(24 weeks)
- Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM(24 weeks)
- Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM(76 weeks)
- Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM(24 weeks)
研究者
研究点 (170)
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