NCT00157339已完成3 期
A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma
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
- 299
- 试验地点
- 1
- 主要终点
- To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.
研究概览
简要总结
Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 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 1 or type 2 diabetes
- •asthma or COPD
排除标准
- •Current smoking habit
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: injected insulin (Drug)
结局指标
主要结局
To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.
时间窗: 12 months
次要结局
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays.(12 months)
- To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months.(12 months)
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin)(12 months)
- To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.(throughout the study)
研究者
研究点 (1)
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