NCT00099515已完成2 期
Standard Training Versus Intensive Training for HIIP Delivery System Usage in Insulin-Naïve Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP
研究概览
简要总结
The purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 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 2 diabetes for at least 12 months
- •Age 18 or older.
- •Taking at least 1 oral antihyperglycemic medication.
- •Have an HbA1C between 7.5 and
- •Be a nonsmoker
排除标准
- •Body Mass Index (BMI) greater than
- •Have frequent episodes of severe hypoglycemia.
- •Have advanced autonomic neuropathy.
- •Have history of asthma.
- •Have chronic obstructive pulmonary disease (COPD).
研究组 & 干预措施
A
Experimental
干预措施: LY041001 (HIIP) (Drug)
B
Experimental
干预措施: LY041001 (HIIP) (Drug)
结局指标
主要结局
Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP
时间窗: 4 weeks
次要结局
- Assess the suitability of the HIIP delivery system for type 2 diabetes patients(4 weeks)
- Compare the SMBG profiles of preprandial HIIP administration with standard training and with intensive training Assess patient compliance with the HIIP delivery system Directions for Use (DFU) provided by the Sponsor with and without intensive training(4 weeks)
- Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training(4 weeks)
研究者
研究点 (1)
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