A Double-Blind clinical trial of Benfotiamine Treatment in Diabetic Nephropathy - Benfotiamine in Diabetic Nephropathy

Isala Klinieken0 个研究点目标入组 86 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•Diabetes mellitus, with onset of disease after the age of 40 years
•Age: 50-70 years
•Patients are on treatment with angiotensin converting enzyme inhibitors (ACEi) and/or angiotension II antagonists (AIIA) in an unchanged dose for at least 3 months
•Active diabetic nephropathy as indicated by presence of microalbuminuria (30-300 mg/24 h urine) in at least two samples within 2-6 weeks in advance of inclusion in the trial
•HbA1c < 8.5%, a higher HbA1c < 9.5% is acceptable if the treating phycisian and the patient have accepted that striving for lower values is an unreachable goal (patients with high HbA1c values are the ones that one would expect to be benefit most from treatment with benfotiamine)
•eGFR (estimated by MDRD formula) > 30 ml/min
•Males and postmenopausal females
•Written informed consent

•Renal impairment by other causes than diabetes
•Stage of the disease more severe than indicated in Inclusion criteria
•(macroalbuminuria or renal insufficiency)
•Severe hypoglycemia during the last 3 months, needing help from another person
•Severe hepatopathy (laboratory values about three times higher than normal)
•Endocrine disorders, e.g. hyper-/hypothyroidism
•Blood pressure > 160/90 mmHg
•Severe cardiac function disturbances and severe heart rhythm disturbances
•Neoplasms
•Severe general diseases or mental disorders making the participation in the study
•Drug abuse
•Female patients during pregnancy and lactation period and female patients with active menses during the past year
•Hypersensitivity to benfotiamine or other constituents of the study medication
•HbA1c >9.5%
•Use of vitamin B containing supplements during the last 3 months
•Use of NSAIDs more than 3 times per week (including self-medication)
•Participation in another study within one month before entering the benfotiamine

发起方

Isala Klinieken