NCT01451398已完成3 期
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere® Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period
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
- 353
- 主要终点
- Change From Baseline to Week 24 in HbA1c
研究概览
简要总结
Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.
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
- Double (Participant, Investigator)
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
- •HbA1c > or = to 7.5% and < or = to 10.0%
- •Body mass index (BMI) < or = to 45 kg/m2
- •Non smoker for at least 6 months before Screening
- •Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
- •Currently receiving as diabetes treatment only metformin or 2 or more OADs and on stable doses for at least 3 months before enrollment
- •Subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose
- •Subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent
- •Subjects receiving a DPP-4 inhibitor must receive the maximum approved dose specific for that agent
- •Metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range
- •No previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes
- •Forced expiratory volume in one second (FEV1) > or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
- •Forced vital capacity (FVC) > or = to 70% NHANES III predicted
- •Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) > or = to NHANES III lower limit of normal (LLN)
排除标准
- •History of chronic obstructive pulmonary disease (COPD), clinically proven 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 (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult)
- •Renal disease or renal dysfunction
- •Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease
- •Previous or current use of amiodarone
- •Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening
- •History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening
- •History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements
研究组 & 干预措施
TI inhalation powder
Experimental
Technosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs
干预措施: Technosphere® Insulin (Drug)
Technosphere powder
Placebo Comparator
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs
干预措施: Technosphere Powder (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in HbA1c
时间窗: Baseline to Week 24
Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24
次要结局
- Total Hypoglycemia Event Rate(Baseline to Week 24)
- Mean 7-point Glucose Baseline Values(Baseline)
- Proportion of Responders Achieving HbA1c <= 6.5%(Week 24)
- FPG Change From Baseline to Week 24(Baseline to Week 24)
- Time to Rescue(Baseline to Week 24)
- Severe Hypoglycemia Event Rate(Baseline to Week 24)
- Change in Body Weight From Baseline to Week 24(Baseline to Week 24)
- FEV1 Change From Baseline to Week 24(Baseline to Week 24)
- Proportion of Responders Achieving HbA1c <= 7.0%(Week 24)
- Proportion of Subjects Requiring Rescue Therapy(Baseline to Week 24)
- Mean 7-point Glucose Week 24 Values(Week 24)
- Incidence of Total Hypoglycemia(Baseline to Week 24)
- Incidence of Severe Hypoglycemia(Baseline to Week 24)
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