A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.
研究概览
简要总结
A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.
This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.
The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.
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 diabetes for at least 24 months
- •Have an HbA1c less than or equal to 11%
- •Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
- •Non-smoker
排除标准
- •Require a daily total insulin dosage greater than 150 U at screening
- •Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
- •Systemic glucocorticoid therapy
- •Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- •History of lung transplantation and/or lung cancer
- •Diagnosed with pneumonia in the 3 months prior to screening
- •History of renal transplantation
- •Active or untreated malignancy
研究组 & 干预措施
2
干预措施: Insulin Glargine (Drug)
1
干预措施: Human Insulin Inhalation Powder (Drug)
1
干预措施: Insulin Glargine (Drug)
2
干预措施: Injectable insulin (Drug)
结局指标
主要结局
To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.
时间窗: 6 months
次要结局
- Insulin antibody binding levels(baseline, 1 month, 6 months, follow-up)
- To compare HbAlc change(6 months)
- Insulin dose requirements(throughout the study)
- To assess rate and incidence of hypoglycemia(6 months)