NCT01357252已完成3 期
A Multicenter, Double-blind, Randomized, Parallel-group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50mg qd to Placebo as add-on Therapy to Glimepiride in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy.
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
- 279
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of T2DM by standard criteria
- •Patients who have received a stable dose of SU for at least 12 weeks prior to Visit 1
- •HbA1c ≥7.5% to ≤ 11.0% at Visit 1 and Visit 3 (Week -1)
- •Age: ≥18 to ≤ 80 years at Visit
- •BMI ≥ 20 and ≤ 40 kg/m^2 at visit 1.
排除标准
- •FPG ≥ 270mg/dl (15.0 mmol/L) at Visit 1 or Visit 3 (Week -1)
- •Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4)
- •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
Change from baseline in HbA1c
时间窗: 24 weeks
次要结局
- Safety and tolerability (Frequency of adverse events, serious adverse events, and notable laboratory abnormalities) of add-on therapy with vildagliptin 50 mg qd to glimepiride as compared to pbo(24 weeks)
- Change from baseline in Fasting Plasma Glucose(24 weeks)
- Responder rates - proportion of subjects reaching predefined HbA1c targets(24 weeks)
研究者
研究点 (1)
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