A Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint.
研究概览
简要总结
A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Insulin naive
- •One or more oral antihyperglycemic medications
- •HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
- •Non-smoker
排除标准
- •Taking a TZD dose greater than what is indicated
- •Have not taken insulin within 6 months of entry into study
- •Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
- •Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
- •Have had pneumonia in the 3 months prior to study entry
- •Systemic glucocorticoid therapy
- •Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- •History of renal transplantation
- •Have an active or untreated malignancy
- •Have a current diagnosis or past history of clinically relevant pulmonary disease
- •Taking or have taken exenatide during the 6 weeks prior to study entry
研究组 & 干预措施
1
4 week pretreatment phase consists of continuation of usual OAM therapy
24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation
8 week follow up period
干预措施: Human Insulin Inhalation Powder (Drug)
1
4 week pretreatment phase consists of continuation of usual OAM therapy
24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation
8 week follow up period
干预措施: Insulin Glargine (Drug)
2
4 week pretreatment phase consists of continuation of usual OAM therapy
24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation
8 week follow up period
干预措施: Human Insulin Inhalation Powder (Drug)
2
4 week pretreatment phase consists of continuation of usual OAM therapy
24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation
8 week follow up period
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint.
时间窗: 56 weeks
次要结局
- Mean change in HbA1c from baseline to various timepoints(56 weeks)
- Insulin dose requirements(56 weeks)
- Adverse events(throughout the study)
- Patient-reported outcomes of W-BQ12(screening,baseline, week 12,24, and 48)
- Hypoglycemia rate(throughout the study)
- Safety as assessed by total pulmonary function testing and fasting lipid profile(throughout the study)
- Assess inhaler reliability.(throughout the study)
- Changes in body weight(every visit)
- Patient Reported outcomes of DSC-R(screening,baseline, week 12,24, and 48)
- Patient reported outcomes of DTSQS(screening,baseline, week 12, 24 and 48)
- Patient reported outcome of preference questionnaire(week 48)
- Patient reported outcome of IDSQ(week 12, 24, and 48)
- Patient reported outcome of Expectations About Insulin Therapy Questionnaire(screening,baseline)
- Patient reported outcome of Experience with Insulin Therapy Questionnaire(week 12, 24 and 48)