An Open-Label, Phase 2, Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus Participating in Extension Protocols 217-102, 103, or 104
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
研究概览
简要总结
This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).
详细描述
The study was terminated on Oct. 18, 2007. This study is not a post approval commitment study. Pfizer decided to cancel new trials because of the decision to withdraw Exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols
排除标准
- •Pregnancy
研究组 & 干预措施
Exubera® (inhaled insulin)
Open label, no comparator
干预措施: Exubera® (inhaled insulin) (Drug)
结局指标
主要结局
Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
时间窗: Baseline to 126 months
Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
时间窗: baseline to 126 months
Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
次要结局
- Hypoglycemic Event Rates by Interval of Exubera Treatment(0 to 132 months)
- Severe Hypoglycemic Event Rates by Interval of Exubera Treatment(0-132 months)
- Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes(36 months to 126 months)
- Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)(36 to 126 months)
- Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)(6 to 120 months)
- Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment(3 to >=108 months)
- Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment(3 to >=108 months)
- Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment(6 to >=108 months)
- Change in Glycosylated Hemoglobin by Duration of Exubera Treatment(Baseline to 126 months)