A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 1
- 主要终点
- To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.
研究概览
简要总结
A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder [also known as AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.
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 mellitus
- •one or more oral antihyperglycemic medications
- •once-daily insulin glargine
- •HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
- •Non-smoker
排除标准
- •taking a TZD dose greater than what is indicated
- •more than two episodes of severe hypoglycemia during the 6 months prior
- •Have had a lower respiratory infection in the 3 months prior
- •systemic glucocorticoid therapy
- •clinical signs or symptoms of liver disease, acute or chronic hepatitis
- •history of renal transplantation
- •Have an active or untreated malignancy
- •Require more than 150 U/day of insulin glargine
研究组 & 干预措施
1
Intensified Glargine
干预措施: Insulin Glargine (Drug)
2
HIIP
干预措施: Human Insulin Inhalation Powder (Drug)
3
Intensified Glargine plus HIIP
干预措施: Human Insulin Inhalation Powder (Drug)
3
Intensified Glargine plus HIIP
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.
时间窗: 24 weeks
次要结局
- To assess rate and incidence of hypoglycemia(24 and 52 weeks)
- To assess insulin dose requirements(24 and 52 weeks)
- To measure changes in HbA1c over time(24 weeks)