NCT00308308已完成3 期
A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up
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
- 589
- 试验地点
- 127
- 主要终点
- Compare the Mean Change From Baseline to Week 52 in HbA1c
研究概览
简要总结
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 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
- 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
- 是
入选标准
- •Clinical diagnosis of type 1 diabetes for at least 1 year
- •Nonsmokers for prior 6 months
- •BMI less than or equal to 35kg/m2
- •HbA1c > or = 7% and < or = 11%
- •Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects
- •FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
- •Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
- •Urine cotinine < or = 100 ng/mL
排除标准
- •History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
- •Evidence of severe complications of diabetes
- •Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal
研究组 & 干预措施
1
Experimental
Technosphere Insulin
干预措施: Technosphere Insulin (Drug)
2
Active Comparator
Rapid-acting analogue insulin plus basal insulin glargine
干预措施: Active comparator (Drug)
结局指标
主要结局
Compare the Mean Change From Baseline to Week 52 in HbA1c
时间窗: Baseline to Week 52
次要结局
- Change From Baseline in Weight to Week 52(Baseline to Week 52)
- Change From Baseline in Fasting Plasma Glucose to Week 52(Baseline to Week 52)
- Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%(Baseline to Week 52)
- Incidence of Total Hypoglycemia(Baseline to Week 52)
- Incidence of Severe Hypoglycemia(Baseline to Week 52)
- Total Hypoglycemia Event Rate(Baseline to Week 52)
- Severe Hypoglycemia Event Rate(Baseline to Week 52)
研究者
研究点 (127)
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