Efficacy and Safety of Exubera (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 1 Diabetes Mellitus: A Long-Term, Outpatient, 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
- 582
- 试验地点
- 1
- 主要终点
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).
This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.
详细描述
Pfizer announced in October 2007 that it would stop marketing Exubera. 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 A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus
排除标准
- •severe asthma or COPD
- •brittle diabetes
研究组 & 干预措施
Subcutaneous Insulin
干预措施: Subcutaneous Insulin (Drug)
Inhaled Insulin
干预措施: Inhaled Insulin (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
时间窗: Baseline through Extension Follow-up Month 3
Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation \[FEV1\] in liters \[L\] at observation minus Baseline value).
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
时间窗: Month 3 through Extension Follow-up 3
Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
时间窗: Baseline through Extension Follow-up Month 3
Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity \[DLco\] measured in milliters/minutes/millimeters of mercury \[mL/min/mmHg\] at observation minus Baseline value).
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
时间窗: Month 3 through Extension Follow-up Month 3
Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.
Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Week -2 through Extension Follow-up Month 6 or end of study
Annual rate of change in FEV1 calculated as slope over time \[visit\] for forced expiratory volume in 1 second measured as liters per year (L/yr).
Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
时间窗: Week -2 through Extension Follow-up Month 6 or end of study
Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline through Extension Follow-up Month 3)
- Hypoglycemic Event Rates(Month 1 through Extension Month 39)
- Severe Hypoglycemic Event Rates(Month 1 through Extension Month 39)
- Change From Baseline in Fasting Plasma Glucose(Baseline through Extension Follow-up Month 3)
- Change From Baseline Body Weight(Baseline through Extension Follow-up Month 3)
- Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)(Month 3 through Extension Month 39)
- Total Daily Long-Acting Insulin Dose Adjusted for Body Weight(Month 3 through Extension Month 39)
- Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)(Month 3 through Extension Month 39)
- Total Daily Short-Acting Insulin Dose Adjusted for Body Weight(Month 3 through Extension Month 39)
- Baseline Dyspnea Index (BDI)(Week - 1)
- Transition Dyspnea Index (TDI)(Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study)
- Lipids(Week -4 through Month 24)
- Cough Questionnaire(Week 0 and if indicated through Extension Follow up Month 3)
- Forced Vital Capacity (FVC)(Week -3 through Extension Follow-up Month 6 or End of Study)
- Total Lung Capacity (TLC)(Week -3 through Extension Follow-up Month 6 or End of Study)
- Insulin Antibodies(Baseline through Extension Month 39)