NCT00490854已完成2 期
A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents
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
- 129
- 试验地点
- 1
- 主要终点
- Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase
研究概览
简要总结
The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.
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
- 20 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
- •One or more oral antihyperglycemic medications for at least 12 weeks
- •HbA1c equal to or greater than 7.0%, and equal to or less than 10.5%
- •Nonsmokers, have not smoked for at least 6 months and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
- •Satisfactory lung function results to meet the requirement of the study
排除标准
- •Previously received any form of inhaled insulin
- •Have a current diagnosis or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
- •History or presence of liver disease
- •History or presence of kidney disease
研究组 & 干预措施
1
Experimental
干预措施: Neutral protamine hagedorn insulin (Drug)
1
Experimental
干预措施: Human Insulin Inhalation Powder (Drug)
2
Experimental
干预措施: Human Insulin Inhalation Powder (Drug)
2
Experimental
干预措施: Neutral protamine hagedorn insulin (Drug)
结局指标
主要结局
Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase
时间窗: 24, 48 and 76 weeks after Randomization
次要结局
- 8-point SMBG profiles.(24, 48 and 76 weeks after Randomization)
- Mean change in HbA1c from baseline to the end.(24, 48 and 76 weeks after Randomization)
- Mean dosage of both preprandial and basal insulin.(24, 48 and 76 weeks after Randomization)
- Inhaler reliability.(24, 48 and 76 weeks after Randomization)
- Patient-reported outcomes questionnaires.(24, 48 and 76 weeks after Randomization)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study for Patients With Type 1 Diabetes MellitusDiabetes Mellitus, Type 1NCT00447213Eli Lilly and Company70
已完成
3 期
Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00437112Eli Lilly and Company142
已完成
2 期
To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.Diabetes Mellitus, Type 2NCT00419302Mannkind Corporation16
已完成
4 期
Human Insulin NPH and Insulin Aspart in Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT00597233Novo Nordisk A/S91
已完成
1 期
A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra TabletHealthyNCT01509196Hanmi Pharmaceutical Company Limited28