NCT00332826终止3 期
A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 153
- 主要终点
- The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
研究概览
简要总结
The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
- •Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
- •Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
- •Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.
- •Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
- •Body mass index (BMI) < 40kg/m2
- •HbA1c >6.0% to <11.5%
排除标准
- •Severe complications of diabetes in the opinion of the investigator
- •Seizure disorder
- •Significant cardiovascular dysfunction and/or history within 3 months of screening
- •Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.
- •Clinical nephrotic syndrome or renal dysfunction or disease
- •Total daily insulin requirement of >1.4 U/kg body weight
- •Clinical diagnosis of Step 4 asthma
- •Use of >6 puffs/day of fast acting bronchodilator
- •Currently using an insulin delivery pump
- •Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
- •Two or more severe hypoglycemic episodes within the past 6 months.
- •Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
- •Current use of systemic steroids
- •Subjects who currently smoke tobacco or who have smoked within the past 6 months
- •Urine cotinine test of > 100ng/ml
- •Current drug or alcohol abuse
- •Clinically significant abnormalities on screening laboratory evaluation
- •Cancer within the past 5 years or any history of lung neoplasms
- •History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
- •Active infection or history of severe infection with 30 days of screening.
- •History of anaphylaxis and/or angioneurotic edema
- •Diagnosis of chronic obstructive pulmonary disease (COPE)
- •Previous exposure to any inhaled insulin product
结局指标
主要结局
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
次要结局
未报告次要终点
研究者
研究点 (153)
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