NCT00437489终止4 期
A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline
研究概览
简要总结
The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.
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
- •Diabetes mellitus Type 2
- •Currently treated with at least 2 oral anti-diabetic agents
排除标准
- •Severe Asthma, severe COPD
研究组 & 干预措施
Control
Active Comparator
干预措施: Inhaled Human Insulin (Exubera) (Drug)
Experimental
Experimental
干预措施: Inhaled Human Insulin (Exubera) (Drug)
结局指标
主要结局
Change in HbA1c From Baseline
时间窗: From baseline to week 16
Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16
次要结局
- Hypoglycemia Event Rate Per Month(up to week 4 or 16)
- Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)(From baseline to week 16)
- Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia(week 16)
研究者
研究点 (1)
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