Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, 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
- 105
- 试验地点
- 1
- 主要终点
- Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.
详细描述
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. 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 A2171030 was terminated on June 17, 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
- 30 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
- •Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1 < 80% predicted and/or a history of chronic productive cough.
排除标准
- •Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking
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 Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).
Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)
时间窗: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).
次要结局
- Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)(Duration of the study)
- Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)(Duration of the study)
- Other PFTs (Besides FEV1 and DLco)(Duration of the study)
- Bronchodilator Responsiveness as Determined by the Change in FEV1(Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52)
- Insulin Dose Responsiveness for FEV1(Baseline, Week 9, Week 51)
- Insulin Dose Responsiveness for DLco(Baseline, Week 9, Week 51)
- Methacholine PC20(Duration of the study)
- Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used(Duration of the study)
- Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations(0 to 1 week to > 9 months)
- Incidence of Severe COPD Exacerbations(0 to 1 week to > 9 months)
- Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires(Duration of the study)
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, Weeks 6, 12, 26, 39, and 52)
- Change From Baseline in Fasting Plasma Glucose(Baseline, Weeks 6, 12, 26, 39, 52)
- Change From Baseline in Body Weight(Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52)
- Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)(Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52)
- Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)(Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52)
- Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)(Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52)
- Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)(Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52)
- Lipids(Duration of the study)
- Hypoglycemic Event Rates(0 to1 month to > 11 months)
- Severe Hypoglcyemic Event Rates(0 to 1 month to > 11 months)