NCT00424437已完成3 期
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 320
- 试验地点
- 36
- 主要终点
- Primary outcome is 24 week change in baseline in HbA1c
研究概览
简要总结
To determine, in subjects with Type 1 Diabetes Mellitus:
- Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day.
- The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes for more than 1 year
- •Stable insulin regimen of at least 2 injections per day
排除标准
- •Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
- •Subjects on insulin pump during 2 months prior to screening.
- •Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
结局指标
主要结局
Primary outcome is 24 week change in baseline in HbA1c
次要结局
- The secondary endpoints include the following efficacy assessments:
- Incidence of hypoglycemia
- Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
- Change from baseline in fasting lipid profile
- Change from baseline in fasting plasma glucose level
- Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
- Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
- Change from baseline in body weight
- Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).
- Patient satisfaction and preference.
研究者
研究点 (36)
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