Effect of Lixisenatide on arterial stiffness in patients with diabetic nephropathy

King’s College London and Guy’s and St Thomas’ NHS Foundation Trust0 个研究点目标入组 120 人开始时间: 2017年2月1日最近更新: 2019年4月8日

适应症

试验速览

暂无简介。

•1. Written informed consent
•2. Aged 40 years and over
•3. Type 2 diabetes mellitus
•4. Diabetic nephropathy, defined as a history of an elevated AER [albumin:creatinine ratio (ACR) =2.5mg/mmol in men and =3mg/mmol in women or AER =20mcg/min] or positive urine dipstick result for proteinuria or urine protein creatinine ratios (PCR)>15 mg/mmol or clinical evidence of diabetic nephropathy] in the absence of other causes of renal damage or urinary tract infections
•5. Estimated glomerular filtration rate (eGFR)* =45 ml/min
•6. On anti-hypertensive therapy with renin angiotensin system (RAS) inhibitor at a stable dose for at least 1 month prior to randomisation
•7. HbA1c between 7% and 12% on anti-diabetic medications
•8. Body mass index =30 kg/m2

•1. eGFR< 45 ml/min
•2. Recent (within 1 year) history of CVD event
•3. Uncontrolled hypertension defined as systolic BP and diastolic BP greater than 180 and 110mmHg respectively
•4. Pregnancy or lactation
•5. Females of child bearing potential or males able to father a child who do not agree to useing suitable methods of contraception
•6. Very poorly controlled diabetes defined as HbA1c > 12%
•7. Non-diabetic renal disease
•8. Expected to receive an increase in the dose of RAS inhibitors during the course of study
•9. History of pancreatitis
•10. Active gastrointestinal (GI) or biliary disease
•11. Planned major GI surgery that can/could affect upper GI function
•12. History or family history of thyroid cancer or multiple endocrine neoplasia 2
•13. Known allergy/intolerance to GLP-1 receptor agonist treatment, metacresol or any of the IMP or placebo components
•14. Involved in current research or have recently (within 30 days ) been involved in any research involving an IMP prior to recruitment
•15. Insufficient understanding of the Trial or unable to comply with study requirements
•16. On basal insulin and a sulphonylurea at randomisation visit
•17. Already on a GLP-1 receptor agonist therapy

发起方

King’s College London and Guy’s and St Thomas’ NHS Foundation Trust