NCT00539890已完成3 期
A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 65
- 主要终点
- Mean change in HbA1c from baseline to treatment week 24
研究概览
简要总结
To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%.
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
- •At least 2 years since diagnosis of type 2 diabetes mellitus
- •Received subcutaneous (sc) insulin for at least 3 months
- •Body Mass Index <44 kg/m2
- •HbA1c>7.0% and <11.5%
- •Serum creatinine <2.0 mg/dL for males and <1.8 mg/dL for females
- •Baseline FVC and FEV1>70% and < 125% of predicted normal
排除标准
- •Significant hepatic disease (AST/ALT3 x ULN)
- •Diagnosis of Type 1 diabetes
- •Severe complications of diabetes
- •History of moderate to severe ketoacidosis within the past 3 months
- •Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days
- •Diagnosis of HIV
- •Positive serology for hepatitis B or C
- •COPD, emphysema, or asthma
- •Current smokers or smoking history within the past 6 months
- •Major psychiatric disorder precluding satisfactory completion of protocol
- •Clinically significant heart disease disease, stroke or heart attack within the past 6 months
- •Treatment with an investigational drug within 30 days
- •Previous treatment with Technosphere/Insulin
- •History of malignancy in the past 5 years except basal cell carcinoma
- •Anemia (hemoglobin <10.5 g/dL for females and <11.5 g/dL (for males)
- •Women who were pregnant of lactating
- •History of hypersensitivity to drugs resembling FDKP carrier products
- •Treatment with another inhaled insulin product during the duration of the study
结局指标
主要结局
Mean change in HbA1c from baseline to treatment week 24
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (65)
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