NCT00308737已完成3 期
Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.
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
- 2,053
- 试验地点
- 172
- 主要终点
- Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
研究概览
简要总结
Pulmonary Safety in Diabetics with T/I
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For All Subjects:
- •Nonsmoking
- •Body mass index <42 kg/m2
- •FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
- •No abnormalities in screening pulmonary radiology
- •For Subjects with diabetes mellitus:
- •Type 1 or type 2 diabetes for at least 2 years
- •HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
- •For Subjects without abnormalities in glucose control:
- •No history of diabetes
- •Normal results from a formal glucose tolerance test
排除标准
- •History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
- •Significant renal, hepatic, or cardiac disease
- •Women who are pregnant, lactating, or planning on becoming pregnant
- •Subjects who have participated in studies of other investigational drugs within the previous 3 months
- •Evidence of severe complications of diabetes
研究组 & 干预措施
TI Inhalation Powder
Experimental
Technosphere® Insulin Inhalation Powder
干预措施: Technosphere® Insulin Inhalation Powder (Drug)
Usual care
Other
Usual care
干预措施: Usual Care (Drug)
结局指标
主要结局
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
时间窗: Baseline to Month 24
Change from Baseline to End of Study in FEV1 by MMRM
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
时间窗: Baseline to Month 24
FEV1 decrease of ≥ 15% from Baseline value at last measurement
次要结局
- Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care(Baseline to Month 24)
- Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement(Baseline to Month 24)
- Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care(Baseline to Month 24)
- Change in Weight From Baseline at Month 24(Baseline to Month 24)
- Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement(Baseline to Month 24)
- Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement(Baseline to Month 24)
- Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM(Baseline to Month 24)
- Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM(Baseline to Month 24)
- Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM(Baseline to Month 24)
- Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement(Baseline to Month 24)
研究者
研究点 (172)
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