A double-blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy - Benfotiamine in Diabetic Nephropathy

• Conditions: Diabetic nephropathy is a serious complication of diabetes mellitus, which is the leading cause of end-stage renal disease (ESRD).Benfotiamine has been shown to reduce diabetic nephropathy and retinopathy in animal experimental models. We investigate the effect of benfotiamine supplementation in patients with diabetic nephropathy, and hypothesize that it will slow down the progression to ESRD.

• Registration Number: EUCTR2007-001755-19-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 angiotensin 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 physician 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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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 (liver function enzymes 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
• Neoplasm
• Severe general diseases or mental disorders making the participation in the study
impossible
• 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 3x per week (including self-medication)
• Participation in another study within one month before joining the benfotiamine
study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified