A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
研究概览
简要总结
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:
Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.
Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.
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 for at least 6 months
- •Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
- •Patients who have been treated with the following regimen:
- •One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),
- •have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
- •are candidates for insulin therapy, in the opinion of the investigator.
排除标准
- •Pregnancy
- •History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
- •Diagnosed with pneumonia in the 3 months prior to screening
- •Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
- •History of renal transplantation
- •History of lung transplantation
- •Active or untreated malignancy
- •Treated with Incretin mimetics
研究组 & 干预措施
2
干预措施: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder (Drug)
1
干预措施: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder (Drug)
结局指标
主要结局
Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
时间窗: 6 months
次要结局
- Insulin dose(throughout the study)
- Treatment satisfaction(6 months)
- Mean change in HbA1c from baseline to various endpoints.(6 months)
- Patient reported outcome from W-BQ12(screening,baseline,month 6)
- Patient safety(throughout the study)
- Patient reported outcome from DSC-R(screening,baseline, month 6)
- Patient reported outcome from DTSQS(screening,baseline, month 6)
- Patient reported outcome from IDSQ(Month 1, 2 and 6)
- Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"(baseline, screening, month 6)