NCT00391027已完成4 期
A Six Month, Open-Label Outpatient, 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
- 261
- 试验地点
- 62
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
研究概览
简要总结
To compare efficacy and safety of Exubera® vs Lantus® in patients with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus, Type 2 on oral agents
- •Age > 30 years
排除标准
- •Severe Asthma, severe Chronic Obstructive Pulmonary Disease
研究组 & 干预措施
Insulin Glargine (Lantus®)
Active Comparator
干预措施: Insulin Glargine (Lantus®) (Drug)
Inhaled Human Insulin (Exubera®)
Active Comparator
干预措施: Inhaled Human Insulin (Exubera®) (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
时间窗: Baseline, Week 26
Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.
次要结局
- Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)(Baseline, Week 26)
- Number of Subjects With Hypoglycemic Events by Severity(Week 26)
- Number of Events of Nocturnal Hypoglycemia(Week 26)
- Change From Baseline in Body Weight(Baseline, Week 26)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 26)
- Number of Subjects Discontinued Due to Insufficient Clinical Response(Week 26)
- Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients(Baseline, Week 26)
- Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)(Baseline, Week 26)
- Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)(Baseline, Week 26)
- Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)(Baseline, Week 26)
- Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)(Baseline, Week 26)
- Change From Baseline in HbA1c Prior to Week 26(Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18)
- Number of Subjects With HbA1c < 6.5 %(Week 26)
- Number of Subjects With HbA1c < 7.0 %(Week 26)
- Number of Subjects With HbA1c < 8.0 %(Week 26)
- Change From Baseline in Fasting Plasma Glucose (FPG) Level(Baseline, Week 26)
研究者
研究点 (62)
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