NCT00063128已完成2 期
Safety and Efficacy 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
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- test the hypothesis that preprandial HIIP plus insulin glargine is noninferior to preprandial injectable insulin (regular human insulin or insulin lispro) plus insulin glargine with respect to HbA1c
研究概览
简要总结
This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.
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
- •You are at least 18 years old.
- •You have had type 1 diabetes for at least 2 years.
- •You are injecting insulin lispro (Humalog), an insulin lispro mixture (Humalog Mixture), regular human insulin mixture (Humulin mixture) before meals using a syringe or injection pen, not an insulin pump.
- •If you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study.
- •You have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.
排除标准
- •You have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin.
- •You have a history of asthma or allergies.
- •You have a chronic cough.
- •You have had a kidney transplant, are on dialysis, or have poor kidney function.
- •You have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.
研究组 & 干预措施
A
Experimental
干预措施: insulin (Drug)
B
Active Comparator
干预措施: human insulin inhalation powder (HIIP) (Drug)
结局指标
主要结局
test the hypothesis that preprandial HIIP plus insulin glargine is noninferior to preprandial injectable insulin (regular human insulin or insulin lispro) plus insulin glargine with respect to HbA1c
时间窗: 12 weeks per therapy
次要结局
- compare the pharmacokinetics of test doses of preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro) administered to a subgroup of patients
- compare 7-point self-monitored blood glucose profiles (blood glucose measurements before & 2 hours after start of morning, midday, evening meals, and blood glucose measurement at bedtime) for preprandial HIIP and preprandial inject
- assess the safety of HIIP using pulmonary function tests, chest x rays, insulin antibody titers, adverse events (AEs), and episodes of hypoglycemia
- assess symptoms of diabetes, patient vitality, and patient satisfaction with the diabetes treatments
- compare insulin dose requirements (both preprandial and basal insulin [insulin glargine]) of patients administering preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro
- assess insulin inhaler reliability
- assess patient compliance with the HIIP delivery system Directions for Use (DFU)
- assess the impact of practice inhalations on inspiratory flow parameters (peak inspiratory flow rate [IFR] and total inspired volume [TIV]) achieved by patients using the insulin inhaler following training with the DFU
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With AsthmaDiabetes MellitusAsthmaNCT00139659Pfizer288
终止
3 期
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPDDiabetes MellitusChronic Obstructive Pulmonary DiseaseNCT00138671Pfizer105
Unknown
4 期
Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021type1diabetesType2 DiabetesNCT05089942Zhejiang Provincial People's Hospital16
已完成
3 期
An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT02561078Eli Lilly and Company420
终止
3 期
Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00469586Novo Nordisk A/S174