CTRI/2010/091/001110已完成3 期
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with the Combination of Metformin and Sulfonylurea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
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
- •Written Informed Consent
- •- Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c more or equal 7 percentage and less or equal 10 percentage) despite being on combination of metformin and sulfonylurea for at least 8 weeks.
- •- BMI less or equal 40 kg/m2
排除标准
- •- Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with more 10% weight loss in 3 months prior to entry, or other signs and symptoms
- •- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- •- Current or prior use (within 3 months of entry) of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin, gliclazide, gliclazide MR or glimepiride)
- •- Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
- •- Estimated CrCl less 60ml/min
- •- CHF (NYHA class III or IV) and/or LVEF less 40%
- •- Active liver disease and/or significant abnormal liver function
- •- Creatine kinase more or equal 10 x ULN
研究者
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