An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Self-Monitoring Blood Glucose Levels: Change From Baseline
研究概览
简要总结
Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers)
详细描述
Pfizer announced in October 2007 that it would stop marketing CP-464,005. At that time recruitment for study, A2171105 was placed on hold. Nektar, the company from which Pfizer licensed CP-464,005, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171105 was terminated on April 10, 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
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic criteria for diabetes.
排除标准
- •Patients who have smoked during the 6 months prior to screening (smoking shall be prohibited during the term of this study, as well)
- •Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 < 70% of predicted) ) at Week -4.
研究组 & 干预措施
B
Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
干预措施: CP-464,005 (Drug)
C
Type 2 DM who has already treated by Insulin
干预措施: CP-464,005 (Drug)
A
Type 1 DM
干预措施: CP-464,005 (Drug)
结局指标
主要结局
Self-Monitoring Blood Glucose Levels: Change From Baseline
时间窗: One year
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
次要结局
- The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin(0 month to 12 months)
- Daily Inhaled Insulin Dose(Up to 26 weeks)
- The Values of Hemoglobin A1c:Change From Baseline(Baseline, Week 6, Week 12, Week 26, End of treatment)
- The Value of Fasting Plasma Glucose:Change From Baseline(Baseline, Week 6, Week 12, Week 26)
- The Values of Forced Expiratory Volume at 1 Second:Change From Baseline(Beseline, Week 1, Week 2, Week 6, Week 12, Week 26)
- The Values of Forced Vital Capacity:Change From Baseline(Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment)
- The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline(Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment)
- Insulin Antibody Levels : Change From Baseline(Baseline, Week 6, Week 12, End of treatment)