EUCTR2007-004951-12-BG进行中（未招募）不适用
A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Parallel-group, Double-blind, Placebo-controlled Long-term Observational Period
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At visit 1:
- •Provision of informed consent
- •Diagnosed with type 2 diabetes
- •Men or women who are equal to or above 18 years of age
- •Documented history of CrCl less than 50 ml/min within 3 last months
- •WOCBP using an adequate method of contraception
- •Men should take precaution not to father a baby while participating in the study and 4 weeks after
- •At visit 2:
- •HbA1c above or equal to 7.0% and less than or equal to 11.0%
- •C-peptide level above or equal to 0.375nmol/L, 1.0ng/mL
- •Estimated CrCl less than 50 ml/min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At visit 1:
- •Pregnancy or breastfeeding
- •Initiation of insulin therapy within 4 weeks of study entry or unstable insulin therapy within 4 weeks of study entry
- •Allowed oral antidiabetic therapy that has not been stable within the last 4 weeks
- •Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic
- •Treatment with metformin within 4 weeks prior to visit 1
- •Thiazolidinedione tratment has not been stable within 12 weeks of study entry
- •Systemic treatment with oral prednisolone above 10 mg per day or comparable dose of systemic glucocorticoid
- •Treatment with CYP450 3A4 inducers, HIV or antiviral drugs
- •Contraindications to therapy as outlined in the saxagliptin IB
- •Congestive heart failure (NYHA) class III or IV and/or left ventricular ejection fraction equal to or less than 40%
- •Significant cardiovascular history within the past 6 months
- •Type I diabetes, history of diabetic ketoacidosis or hypomolar non-ketonic coma
- •History of 2 or more major hypoglycemic events the last 3 months, haemoglobinopathies, alcohol or illegal drug abuse
- •Donation of blood, plasma or platelets within the last 3 months
- •Involvement in planning or conduct of the study
- •Participating in a clinical study within 90 days
- •Unable to complete the study, protocol or medication non-compliant
- •At visit 2:
- •Active liver disease and/or significant abnormal liver function
- •Creatinine kinase above or equal to 3xULN
- •Clinically significant abnormality
- •Patients receiving peritoneal dialysis, and patients who are expected to initiate peritoneal dialysis whithin 3 months after enrolment
- •Patients expected to have kidney transplant whithin 3 months after enrolment
研究者
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