A double-blind, randomized, placebo-controlled clinical trial on benfotiamine treatment in patients with diabetic nephropathy

Diabetes Care. 2010 Jul;33(7):1598-601. doi: 10.2337/dc09-2241. Epub 2010 Apr 22.

Abstract

Objective: To investigate the effect of benfotiamine on urinary albumin excretion (UAE) and the tubular damage marker kidney injury molecule-1 (KIM-1) in patients with type 2 diabetes and nephropathy.

Research design and methods: Patients with type 2 diabetes and UAE equivalent to 15-300 mg/24 h, despite ACE inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs), were randomly assigned to 12 weeks of benfotiamine (900 mg/day) (n = 39) or placebo (n = 43).

Results: Compared with placebo, benfotiamine treatment resulted in significant improvement of thiamine status (P < 0.001). Benfotiamine treatment did not significantly decrease 24-h UAE or 24-h KIM-1 excretion.

Conclusions: In patients with type 2 diabetes and nephropathy, high-dose benfotiamine treatment for 12 weeks in addition to ACE-Is or ARBs did not reduce UAE or KIM-1 excretion, despite improvement of thiamine status.

Trial registration: ClinicalTrials.gov NCT00565318.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adult
  • Aged
  • Albuminuria / drug therapy*
  • Albuminuria / urine
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Biomarkers / urine
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / urine
  • Diabetic Nephropathies / drug therapy*
  • Diabetic Nephropathies / urine
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Hepatitis A Virus Cellular Receptor 1
  • Humans
  • Kidney Tubules / drug effects
  • Male
  • Membrane Glycoproteins / urine
  • Middle Aged
  • Placebos
  • Receptors, Virus
  • Thiamine / administration & dosage
  • Thiamine / analogs & derivatives*
  • Thiamine / blood

Substances

  • Adjuvants, Immunologic
  • Angiotensin II Type 1 Receptor Blockers
  • Angiotensin-Converting Enzyme Inhibitors
  • Biomarkers
  • HAVCR1 protein, human
  • Hepatitis A Virus Cellular Receptor 1
  • Membrane Glycoproteins
  • Placebos
  • Receptors, Virus
  • Thiamine
  • benphothiamine

Associated data

  • ClinicalTrials.gov/NCT00565318