NCT00325364已完成3 期
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
研究概览
简要总结
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
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
- •Type 2 diabetes
- •Non smoker
- •Normal lung function
排除标准
- •Pulmonary, hepatic, or renal disease
- •Congestive heart failure
- •Active malignancy
- •Systemic glucocorticoid therapy
研究组 & 干预措施
1
Experimental
干预措施: Human Insulin Inhalation Powder (Drug)
2
Active Comparator
干预措施: Injectable insulin (Drug)
结局指标
主要结局
To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
时间窗: 6 months
次要结局
- To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin(24 months)
- To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients(3 months, 6 months)
- To compare inhaled human insulin to injectable insulin over time with respect to change on body weight(baseline and every visit)
- To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction(baseline, 6 months, 12 months, 18 months, 24 months)
- To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c(baseline and every visit)
- To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia(throughout the study)
- To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements(24 months)
- To test dose titration methods(6 months)
- To assess inhaler reliability(throughout the study)
研究者
研究点 (1)
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