NCT00402909已完成4 期
A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Compare the Safety and Efficacy of Nateglinide vs. Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Basal Insulin Glargine in Combination With Metformin and/or Thiazolidinedione (Pioglitazone or Rosiglitazone)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change from baseline in hemoglobin (Hb)_A1c
研究概览
简要总结
This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.
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
- Double
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
- •Male/female, age 18-78 inclusive
- •Type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
- •HbA1c 7.0-8.5% inclusive
- •Fasting plasma glucose <240 mg/dL at screening
- •Body Mass Index 22-41 kg/m2
排除标准
- •Pregnant or nursing
- •Other investigational drugs within 30 days of screening
- •Treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
- •History of type 1 diabetes
- •Abnormal kidney function
- •History of acute diabetic complications
- •Congestive heart failure requiring treatment
- •Myocardial infarction, coronary artery surgery, stroke within 6 months of screening
- •Liver disease, liver enzymes more than 3 times upper limit of normal
- •Fasting triglycerides >700 mg/dL within past 12 weeks
- •Acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
- •Treatment with corticosteroids
- •Blood donation within past 12 weeks
- •Other protocol-defined inclusion/exclusion criterial may apply.
结局指标
主要结局
Change from baseline in hemoglobin (Hb)_A1c
次要结局
- Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%
- Change from baseline in 2-hour postprandial glucose during standardized meal test
- Proportion of patients achieving reduction in HbA1c of 0.5%
研究者
研究点 (2)
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