Safety, Tolerability and Effectiveness of Glocophage®SR in patients with type-2 Diabetes and Chronic Kidney Disease (eGFR 30 to 45mL/minute/1.73m2) - GlucophageSR in patients with type-2 Diabetes & CKD (eGFR 30 to 45)

Hywel Dda Health Board0 个研究点目标入组 50 人开始时间: 2012年8月20日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•Age > 18 years. Male or Female. In addition, patients should fulfill all the following criteria at the randomization visit:
•1.Patients with Type – 2 Diabetes.
•2.Suboptimal glycaemic control {HbA1c = 7.5% (IFCC equivalent = 58mmol/mol)} at the screening visit.
•3.Chronic kidney disease with eGFR = 30mL/minute/1.73m2 to = 45mL/minute/1.73m2 (calculated by MDRD equation) at the screening visit.
•4.Stable renal function (eGFR) in the last three months.
•5.Willing and able to comply with the study protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Previous H/O: M.I. (in last 6 months),
•2.Previous history of Congestive Cardiac Failure (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 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 breast feeding.
•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 DPPIV inhibitors and 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.Excessive alcohol intake where precipitation of lactic acidosis is suspected.
•22.Any other condition excluded in Summary of Product Characteristics (SPC).

发起方

Hywel Dda Health Board