An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7,439
- 试验地点
- 1
- 主要终点
- Rate of Primary Lung Cancer Mortality
研究概览
简要总结
In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.
详细描述
Both retrospective and prospective components All subjects who participated in one of the 17 included Exubera clinical trials will be invited to participate in the current study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Previously participated in an eligible Exubera clinical trial
- •Willing to provide study doctor with at least one alternate contact person
排除标准
- •Participated in an investigational study of an unapproved drug since completing the Exubera trial
- •Ever used an other (non-Exubera) inhaled insulin
研究组 & 干预措施
Previously treated with Exubera
干预措施: Exubera (Drug)
Previously treated with comparator
Subjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial.
干预措施: Randomized diabetes therapy (Other)
结局指标
主要结局
Rate of Primary Lung Cancer Mortality
时间窗: Baseline from original trial up to Year 2 of this study
Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.
次要结局
- Rate of Primary Lung Cancer Mortality Among Former Smokers(Baseline from original trial up to Year 2 of this study)
- Rate of All-cause Mortality(Baseline from original trial up to Year 2 of this study)
- Rate of Primary Lung Cancer Diagnosis(Baseline from original trial up to Year 2 of this study)