NCT00246623已完成3 期
A Randomized, Open-Label, Multicenter Study Assessing the Effects of Forced Exubera Dose Titration on Glycemic Control in Patients With Suboptimally Controlled Type 2 Diabetes on Two or More Oral Antidiabetic Agents
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
- 120
- 试验地点
- 16
- 主要终点
- Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.
研究概览
简要总结
This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, age >= 18 years and <= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10%
- •Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones)
排除标准
- •Type 1 diabetes
- •Smoking within the past 6 months or significant pulmonary diseases
结局指标
主要结局
Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.
次要结局
- Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed.
研究者
研究点 (16)
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