Safety And Efficacy Of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents Ages 6-17 Years With Type 1 Diabetes Mellitus: A 12 Month, Outpatient, Randomized, Open Label, Parallel Group Comparative Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
研究概览
简要总结
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.
详细描述
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for the pediatric study, A2171083, was placed on hold. Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. After this time, Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171083 was terminated and no further recruitment took place.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Type 1 diabetes mellitus for more than 6 months.
- •Males and females ages 6 to 17 years.
- •Subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre prandial dose of short acting subcutaneous insulin.
排除标准
- •Subjects using an insulin pump
研究组 & 干预措施
Inhaled insulin (Exubera)
干预措施: Inhaled insulin (Exubera) (Drug)
Subcutaneous Insulin (subject's prescribed)
干预措施: Subcutaneous Insulin (subject's prescribed) (Drug)
结局指标
主要结局
To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
时间窗: 12 months
No subjects were dosed therefore no data collected.
次要结局
- Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;(12 months)
- Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;(12 months)
- 7 Point Home Glucose(12 months)
- Change From Baseline in FVC(12 months)
- Slope for Other PFT Parameters;(12 months)
- Hypoglycemic Event Rates;(12 months)
- Change From Baseline in Other PFT Parameters(12 months)
- Treatment Preferences.(12 months)
- Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c(12 months)
- Change From Baseline in Insulin Antibodies (microU/mL);(12 months)