An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,976
- 试验地点
- 1
- 主要终点
- Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline
研究概览
简要总结
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.
详细描述
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time, Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar. Following the announcement, enrollment was halted. Subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol. 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, an amendment was filed on April 16, 2008 specifying that all subjects randomized to Exubera had to be transitioned to usual diabetes care, and all study subjects followed for serious adverse events for 6 months. In accordance with this amendment, study A2171069 was terminated on April 29, 2009. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for receiving Exubera treatment based on the approved local label
排除标准
- •Pregnant or lactating
- •Have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study
研究组 & 干预措施
Exubera
干预措施: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care (Drug)
Usual Diabetes Care
干预措施: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care (Drug)
结局指标
主要结局
Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline
时间窗: Baseline, Month 6, Year 1, Year 2, Index Visit
Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.
Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects
时间窗: Baseline, Month 6, Year 1, Year 2, Index Visit
Confirmed FEV1 decline: any two consecutive declines that are \>= 14 days apart. The pulmonary function test that established persistence occured \>= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.
Time to Persistent Decline in FEV1 Exceeding 20% From Baseline
时间窗: Baseline to 5 years
Elapsed time, in days, from the start of subject's participation in the study to the first reading of FEV1 that is: 20% or more below the subject's latest pre-study measurement, subsequently confirmed as a \>20% decline \[(baseline observed value minus visit observed value)/by baseline observed value \*100\], and assessed as persistent as defined by protocol process. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to latest valid FEV1 measurement for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.
次要结局
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1)(Baseline, Week 26, Week 52, Week 104, Index Visit)
- Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis(Baseline through End of Study)
- Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis(Baseline to 5 years)
- All-cause Mortality: Number of Deaths(Baseline through End of Study)
- Time to Event: All-cause Mortality(Baseline to 5 years)
- Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke(Baseline through End of Study)
- Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke(Baseline to 5 years)
- Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm(Baseline through End of Study)
- Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm(Baseline to 5 years)
- Change in Glycosylated Hemoglobin (HbA1c) From Baseline(Baseline to 5 years)