Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 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
- 635
- 试验地点
- 1
- 主要终点
- Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
研究概览
简要总结
This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.
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 A2171029 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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
排除标准
- •Smoking Pregnancy
研究组 & 干预措施
Inhaled Insulin
Inhalable short-acting insulin
干预措施: Inhaled Insulin (Drug)
Subcutaneous insulin
干预措施: Subcutaneous insulin (Drug)
结局指标
主要结局
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 observed DLco \[milliliters per minute per millimeters of mercury (ml/min/mmHg)\] at treatment observation minus baseline value).
Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
时间窗: Week -2 through extension follow up Month 3 or end of study
Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).
Change From Baseline in FEV1
时间窗: Baseline through extension follow up Month 3
Change from baseline: mean of (value of observed FEV1 \[L\] at treatment observation minus baseline value).
Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Month 3 through extension Month 60
Change from Month 3: mean of (value of observed FEV1 \[forced expiratory volume in the first second of forced exhalation\] in liters \[L\] at treatment observation minus Month 3 value).
Annual Rate of Change in FEV1
时间窗: Week -2 through extension follow up Month 3 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).
Summary of ≥ 15 % Decliners in FEV1
时间窗: Month 3 through extension follow up Month 3
Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % \[(baseline observed value - visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.
Summary of ≥ 20 % Decliners in DLco
时间窗: Month 3 through extension follow up Month 3
Number of subjects with a post-baseline DLco decrease of ≥ 20 % \[(baseline observed value - visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.
次要结局
- Change From Baseline in Body Weight(Baseline through extension follow up Month 3)
- Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)(Month 3 through extension Month 36)
- Transition Dyspnea Index (TDI)(Week 4 through extension follow up Month 3 or end of study)
- Forced Vital Capacity (FVC)(Week -3 through extension follow up Month 3 or end of study)
- Total Lung Capacity (TLC)(Baseline through extension follow up Month 3)
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline through extension follow up Month 3)
- Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)(Month 3 through extension Month 36)
- Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)(Month 3 through extension Month 36)
- Total Daily Long-acting Insulin (Adjusted for Body Weight)(Month 3 through extension Month 36)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline through extension follow up Month 3)
- Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides(Week -4 through Month 24)
- Cough Questionnaire(Week 0 and if indicated through extension follow up Month 3)
- High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits(Baseline, M12, M24, Ext M6, Ext M18, Ext M36)
- Baseline Dyspnea Index (BDI)(Week -1)
- Hypoglycemic Event Rates(Month 1 through extension Month 36)
- Severe Hypoglycemic Event Rates(Month 1 through extension Month 36)
- High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits(Baseline, M12, M24, Ext M6, Ext M18, Ext M36)
- Insulin Antibodies(Baseline through extension Month 36)