NCT00332488已完成3 期
A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.
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
- 547
- 试验地点
- 118
- 主要终点
- Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
研究概览
简要总结
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months
- •Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
- •Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
- •HbA1c >or= to 7.5% and < or= to 11.0%
- •BMI < or = to 40kg/m
- •FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%
排除标准
- •Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks
- •Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects
- •History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
- •Evidence of serious complications of diabetes (e.g. autonomic neuropathy)
研究组 & 干预措施
1
Experimental
Technosphere Insulin
干预措施: Technosphere Insulin (Drug)
2
Active Comparator
Metformin & Secretagogues
干预措施: Metformin & Secretagogues (Drug)
3
Experimental
Technosphere & Metformin
干预措施: Technosphere Insulin & Metformin (Drug)
结局指标
主要结局
Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
时间窗: Baseline to Week 12
次要结局
- Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue(Baseline to Week 12)
- Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)(Week 24)
研究者
研究点 (118)
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