Antiproteinuric Effects of Liraglutide Treatment in Patients with Type 2 Diabetes and Albuminuria: A Randomized, Placebo-Controlled Trial - The Liralbu Trial

Steno Diabetes Center0 个研究点目标入组 30 人开始时间: 2014年12月23日最近更新: 2016年11月14日

适应症

试验速览

暂无简介。

•1.Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee
•2.Male or female patients >18 years with type 2 diabetes (WHO criteria).
•3.HbA1c = 48 mmol/mol (6.5 %)
•4.eGFR = 45 ml/min/1.73 m2 (estimated by MDRD formula)
•5.Fertile female patients must use chemical, hormonal or mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomi or have been surgically sterilized or hysterectomised at least six months prior to screening
•6.Patients must be on stable RAAS-blocking treatment (unchanged dose 4 weeks before inclusion)
•7.Geometic mean urine albumin-to-creatinine ratio (UACR) above 100 mg/g at screening (measured in at least two of three consecutive morning spot urine samples)
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1.SBP > 180 mm Hg at screening
•2.Type 1 diabetes mellitus
•3.Chronic pancreatitis / previous acute pancreatitis
•4.Known or suspected hypersensitivity to trial product(s) or related products.
•5.Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors which in the investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening
•6.Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
•7.Inflammatory bowel disease

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