NCT00150410已完成3 期
A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 626
- 试验地点
- 120
- 主要终点
- Glycosylated hemoglobin
研究概览
简要总结
- Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug.
- Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.
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
- •Type 2 diabetes
- •Currently treated and on a stable doses of drugs for the preceding two (2) months
排除标准
- •Type 1 Diabetes
结局指标
主要结局
Glycosylated hemoglobin
次要结局
- insufficient clinical response.
- Change from baseline in fasting plasma glucose. Other secondary efficacy
- endpoints include, body weight, patient reported outcomes, incidence and severity
- of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to
研究者
研究点 (120)
Loading locations...
相似试验
已完成
3 期
Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)Type 2 Diabetes MellitusNCT01545388Merck Sharp & Dohme LLC337
已完成
3 期
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin AloneDiabetes Mellitus, Type 2NCT00095030Bristol-Myers Squibb1,752
Unknown
3 期
Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese PatientsObesityNCT00941382Laboratorios Silanes S.A. de C.V.60
已完成
4 期
Trial for People With Established Type 2 Diabetes During RamadanType 2 DiabetesNCT02292290University of Leicester99
已完成
2 期
Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 DiabeticsType 2 DiabetesNCT00698230Incyte Corporation302