ISRCTN70770260已完成2 期
Safety, tolerability and effectiveness of Glucophage® SR in patients with type 2 diabetes and chronic Kidney disease
West Wales Hospital (UK)0 个研究点目标入组 50 人开始时间: 2012年3月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •1. Age > 18 years
- •2. Male or female
- •3. Patients with Type 2 diabetes
- •4. Suboptimal glycaemic control {HbA1c = 7.5% (IFCC equivalent = 58mmol/mol)} at the screening visit
- •5. Chronic kidney disease with Estimated Glomerular Filtration Rate (eGFR) = 30mL/minute/1.73m2 to = 45mL/minute/1.73m2 at the screening visit
- •6. Stable renal function (eGFR) in the last 3 months
- •7. Willing and able to comply with the study protocol
排除标准
- •1. Previous myocardial infarction (MI) (in last 6 months)
- •2. Previous history of Congestive Cardiac Failure New York Heart Association (NYHA) class III or IV
- •3. Previous history of Chronic obstructive pulmonary disease (COPD)
- •4. Chronic kidney disease with eGFR < 30mL/minute/1.73m2
- •5. Abnormal alanine aminotransferase (ALT) (> 3fold at baseline)
- •6. Hypoglycaemia symptoms unawareness
- •7. History of hypoglycemic episodes requiring 3rd party assistance for reversal in last 12 months
- •8. Uncontrolled Hypertension (BP > 180/100mmHg)
- •9. Pregnant or likelihood of pregnancy during the study
- •10. Females who are breastfeeding
- •11. Proliferative Diabetic retinopathy and/or laser treatment in last 6 months
- •12. History of Diabetic ketoacidosis, lactic acidosis and gasteroparesis
- •13. Current treatment with metformin/Glucophage® SR
- •14. Treatment with metformin/Glucophage® SR in last 3 months prior to screening visit
- •15. History of irritable bowel syndrome
- •16. Previous intolerance to metformin or Glucophage® SR
- •17. Patients currently on dipeptidyl peptidase IV (DPPIV) inhibitors and Glucagon-Like Peptide (GLP) analogues
- •18. History of significant (more than one stone) weight loss in last 6 months
- •19. History of allergic or hypersensitivity reaction to metformin, Glucophage® SR or any insulin
- •20. Patients unable to tolerate minimum 1000mg daily divided dose of Glucophage® SR
- •21. Any other condition excluded in Summary of Product Characteristics (SPC)
研究者
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