CTRI/2010/091/000595已完成3 期
A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,281
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must have a diagnosis of type 2 diabetes
- •Body mass index (BMI) more than or equal to 22 to less than or equal to 45 kg per sqm at screening
- •Patients must be taking a stable dosage of metformin as monotherapy at screening
- •Patients must have a HbA1c between more than or equal to 7percent and less than or equal to 9.5percent at Week 2
- •Patients must have a fasting plasma glucose (FPG) less than or equal to 270 mgperdL ie 15 mmolperL at Week -2
排除标准
- •Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
- •History of diabetic ketoacidosis or type 1 diabetes mellitus
- •History of pancreas or beta-cell transplantation
- •History of active proliferative diabetic retinopathy
- •History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
- •Taken thiazolidinedione therapy in the past 16 weeks before screening
研究者
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