Benfotiamine in Diabetic Nephropathy
Benfo
A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy
2 other identifiers
interventional
86
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of benfotiamine supplementation in patients with diabetic nephropathy, and to determine whether it will slow down the progression to end-stage renal disease (ESRD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2007
CompletedFirst Posted
Study publicly available on registry
November 29, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedNovember 16, 2009
November 1, 2009
1.5 years
November 28, 2007
November 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin
12 weeks
Secondary Outcomes (1)
Change in urinary excretion of: β2 microglobulin, macrophage inhibiting factor (MIF), monocyte chemo-attractant protein-1 (MCP-1), and other advanced glycation end-products (AGEs).
12 weeks
Study Arms (2)
A
ACTIVE COMPARATORB
PLACEBO COMPARATORInterventions
3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
3x 1 film coated tablet daily. Duration: 12 weeks.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- 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
- 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
You may not qualify if:
- Renal impairment by other causes than diabetes
- 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
- Neoplasm's (excluding history of treated skin cancer of the type basal cell carcinoma BCC or squamous cell carcinoma SCC)
- 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
- HbA1c \> 9.5%
- Use of thiamine containing supplements during the last 3 months
- Participation in another study within one month before joining the benfotiamine study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Isalacollaborator
- Wörwag Pharma GmbH & Co. KGcollaborator
- Predictions Networkcollaborator
Study Sites (1)
Isala Klinieken Hospital
Zwolle, 8000 GK, Netherlands
Related Publications (5)
Hammes HP, Du X, Edelstein D, Taguchi T, Matsumura T, Ju Q, Lin J, Bierhaus A, Nawroth P, Hannak D, Neumaier M, Bergfeld R, Giardino I, Brownlee M. Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy. Nat Med. 2003 Mar;9(3):294-9. doi: 10.1038/nm834. Epub 2003 Feb 18.
PMID: 12592403BACKGROUNDBakker SJ, Heine RJ, Gans RO. Thiamine may indirectly act as an antioxidant. Diabetologia. 1997 Jun;40(6):741-2. No abstract available.
PMID: 9222658BACKGROUNDThornalley PJ, Babaei-Jadidi R, Al Ali H, Rabbani N, Antonysunil A, Larkin J, Ahmed A, Rayman G, Bodmer CW. High prevalence of low plasma thiamine concentration in diabetes linked to a marker of vascular disease. Diabetologia. 2007 Oct;50(10):2164-70. doi: 10.1007/s00125-007-0771-4. Epub 2007 Aug 4.
PMID: 17676306BACKGROUNDAlkhalaf A, Kleefstra N, Groenier KH, Bilo HJ, Gans RO, Heeringa P, Scheijen JL, Schalkwijk CG, Navis GJ, Bakker SJ. Effect of benfotiamine on advanced glycation endproducts and markers of endothelial dysfunction and inflammation in diabetic nephropathy. PLoS One. 2012;7(7):e40427. doi: 10.1371/journal.pone.0040427. Epub 2012 Jul 6.
PMID: 22792314DERIVEDAlkhalaf A, Klooster A, van Oeveren W, Achenbach U, Kleefstra N, Slingerland RJ, Mijnhout GS, Bilo HJ, Gans RO, Navis GJ, Bakker SJ. 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.
PMID: 20413516DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
G J Navis, MD, PhD
University Medical Center Groningen
- PRINCIPAL INVESTIGATOR
H JG Bilo, MD, PhD
Isala
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2007
First Posted
November 29, 2007
Study Start
December 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
November 16, 2009
Record last verified: 2009-11