NCT00127634已完成3 期
A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus
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
- 385
- 试验地点
- 2
- 主要终点
- To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.
研究概览
简要总结
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 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 diabetes
- •Non smoker
- •Normal lung function
排除标准
- •Significant pulmonary, hepatic, or renal disease
- •Severe congestive heart failure
- •Active malignancy
- •Systemic glucocorticoid therapy
研究组 & 干预措施
1
Experimental
干预措施: Human Insulin Inhalation Powder (Drug)
1
Experimental
干预措施: Insulin Glargine (Drug)
2
Active Comparator
干预措施: Injectable Insulin (Drug)
2
Active Comparator
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.
时间窗: 24 months
次要结局
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by insulin antibody binding levels, adverse events, and episodes of hypoglycemia(24 months)
- To explore differences in cough and other pulmonary symptoms in patients treated with Human Insulin Inhalation Powder or preprandial injectable insulin using the Pulmonary Symptom Questionnaire.(months 32, 38, 40 and ED visits)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires.(24 months)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety using serial HRCT scans of the chest(24 months)
- To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.(throughout the study)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to FEV1, FVC, and total lung capacity (TLC), and diffusing capacity of the lung for carbon monoxide (DLCO).(24 months)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by Six-Minute Walk Test with the Borg CR10 scale to access perceived exertion.(24 months)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to insulin dose requirements ( total, preprandial, and basal insulin)(24 months)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to proportion of patients who achieve or maintain an HbA1c < 7.0 %.(24 months)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization(24 months)
- To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to glycemic control as assessed by the 8-point self-monitored blood glucose profiles(24 months)
研究者
研究点 (2)
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