NCT00418522已完成4 期
A Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 413
- 试验地点
- 73
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
研究概览
简要总结
This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
- •Screening HbA1c > 7.0%
- •Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione
排除标准
- •Smoking within last 6 months PFTs outside of range
- •Type 1 diabetes mellitus
- •Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
- •Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit
- •However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.
研究组 & 干预措施
Exubera
Experimental
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
干预措施: Inhaled Insulin (Exubera) (Drug)
Insulin glargine
Active Comparator
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
时间窗: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
次要结局
- Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26(Week 26)
- Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26(Week 26)
- Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26(Week 26)
- Change From Baseline in Fasting Plasma Glucose at Week 26(Baseline, Week 26)
- Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26(Baseline, Week 26)
- Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26(Baseline, Week 26)
- Change From Baseline in Lipids at Week 26(Baseline, Week 26)
- Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26(Baseline, Week 26)
- Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26(Baseline, Week 26)
- Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26(Baseline, Week 26)
- Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26(Baseline, Week 26)
- Number of Subjects With Hypoglycemic Events(Months 1 to 7)
- Number of Total Hypoglycemic Events(Months 1 to 7)
- Number of Total Subject Months of Treatment(Months 1 to 7)
- Crude Hypoglycemic Event Rate(Months 1 to 7)
- Number of Nocturnal Hypoglycemic Events(Months 1 to 7)
- Change From Baseline in Body Weight at Week 26(Baseline, Week 26)
- Change From Baseline in Body Mass Index (BMI) at Week 26(Baseline, Week 26)
研究者
研究点 (73)
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