NCT01196104终止3 期
A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 29
- 主要终点
- Change in HbA1c (%) From Baseline to Week 16
研究概览
简要总结
This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.
详细描述
Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 and ≤ 80 years of age
- •Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
- •Body mass index (BMI) ≤ 45 kg/m2
- •Glycated Hemoglobin (HbA1c) > 6.5% and ≤ 10.0%
- •Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
- •Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months
- •Office spirometry at the investigator site
- •Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted
- •Forced vital capacity (FVC) ≥ 65% NHANES III predicted
- •Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)
- •Exclusion criteria:
- •Current or prior treatment with prandial or PreMix (70/30) insulin
- •History of insulin pump use within 6 weeks of Visit 1
- •Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
- •History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
- •Any clinically significant radiological findings on screening chest x-ray
- •Use of medications for asthma, COPD, or any other chronic respiratory conditions
- •Evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy)
- •Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure [New York Heart Association {NYHA} Class III or IV])
- •Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
- •History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)
排除标准
- 未提供
研究组 & 干预措施
Technosphere® Insulin Inhalation Powder (TI)
Experimental
Insulin Glargine and Technosphere® Insulin Inhalation Powder
干预措施: Technosphere® Insulin Inhalation Powder (Drug)
Comparator
Active Comparator
Insulin Glargine and Insulin Aspart
干预措施: Insulin Glargine (Drug)
Technosphere® Insulin Inhalation Powder (TI)
Experimental
Insulin Glargine and Technosphere® Insulin Inhalation Powder
干预措施: Insulin Glargine (Drug)
Comparator
Active Comparator
Insulin Glargine and Insulin Aspart
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
Change in HbA1c (%) From Baseline to Week 16
时间窗: Baseline to Week 16
Change from Baseline in glycated hemoglobin at Week 16
次要结局
- Glycomark and Fructosamine Levels Measured Throughout the Study(Change from baseline to 16 weeks)
- Seven-point Glucose at Randomization and Throughout the Study(Change from baseline to 16 weeks)
- Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)(Change from baseline to 16 weeks)
- Changes in Body Weight at 16 Weeks(Change from baseline to 16 weeks)
- Week 20 (Follow-up) Forced Vital Capacity(Week 20)
- To Evaluate the Effect of Each Treatment on HbA1c(Change from baseline to 16 weeks)
- Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study(Change from baseline to 16 weeks)
- Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study(Change from baseline to 16 weeks)
- Total Number of Cough Episodes(Baseline to Week 16)
- Severe Hypoglycemic Event Rate(Baseline to Week 16)
- Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires(Change from baseline to 16 weeks)
- Baseline Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
- Week 20 (Follow-up) Forced Expiratory Volume in 1 Second(Week 20 (Follow-up))
- Mild or Moderate Hypoglycemic Event Rate(Baseline to Week 16)
- Week 16 Forced Expiratory Volume in 1 Second(Week 16)
- Week 16 Change From Baseline Forced Vital Capacity(Baseline to Week 16)
- Week 16 Forced Vital Capacity(Week 16)
- Number of Subjects Reporting Cough Episodes(Baseline to Week 16)
- Number of Subjects Reporting Intermittent Coughing Episodes(Baseline to Week 16)
- Number of Single Coughing Episodes(Baseline to Week 16)
- Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation(Baseline to Week 16)
- Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second(Baseline to Week 16)
- Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second(Baseline to Week 20)
- Baseline Forced Vital Capacity (FVC)(Baseline)
- Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity(Baseline to Week 20)
研究者
研究点 (29)
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