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Benfotiamine in Diabetic Nephropathy (Benfo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00565318
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : November 16, 2009
Sponsor:
Collaborators:
Isala
Wörwag Pharma GmbH & Co. KG
Predictions Network
Information provided by:
University Medical Center Groningen

Study Description
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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).

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Benfotiamine Drug: Placebo Phase 4

Detailed Description:

There is a worldwide increase in prevalence in type 2 diabetes mellitus, which is being paralleled by an increasing number of patients reaching dialysis because of diabetic nephropathy. Much of the fivefold increase in patients receiving dialysis treatment that occurred over the past two decades is attributable to type 2 diabetes and diabetic nephropathy. Diabetes is now the leading cause of end-stage renal disease (ESRD), with more than 40% of all new cases of ESRD occurring in patients with diabetes.

Benfotiamine has been shown to reduce diabetic nephropathy and retinopathy in animal experimental models. We hypothesize that benfothiamine supplementation in patients with diabetic nephropathy will ameliorate the effects of both albuminuria/proteinuria and hyperglycaemia on oxidative stress and advanced glycation end-products (AGEs) accumulation in renal tissue, and thereby decrease inflammatory responses and fibrotic responses, causing slowing down of progression to ESRD as a consequence.

Intervention:

The intervention duration is 12 weeks for each group.

  • Group A: Benfotiamine (300 mg) 3x 1 film coated tablet daily (900 mg daily dose benfotiamine)
  • Group B: Placebo 3x 1 film coated tablet daily
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy
Study Start Date : December 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: Benfotiamine
3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
Other Names:
  • Milgamma® mono 300, Wörwag Pharma GmbH & Co. KG
  • A11DA05
Placebo Comparator: B Drug: Placebo
3x 1 film coated tablet daily. Duration: 12 weeks.
Other Name: Placebo, Wörwag Pharma GmbH & Co. KG


Outcome Measures
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Primary Outcome Measures :
  1. Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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). [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Active diabetic nephropathy as indicated by presence of microalbuminuria (15-300 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

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 (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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565318


Locations
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Netherlands
Isala Klinieken Hospital
Zwolle, Netherlands, 8000 GK
Sponsors and Collaborators
University Medical Center Groningen
Isala
Wörwag Pharma GmbH & Co. KG
Predictions Network
Investigators
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Study Director: G J Navis, MD, PhD University Medical Center Groningen
Principal Investigator: H JG Bilo, MD, PhD Isala
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alaa Alkhalaf, M.D, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT00565318    
Other Study ID Numbers: BENFO-1
NL17390.075.07
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: November 16, 2009
Last Verified: November 2009
Keywords provided by University Medical Center Groningen:
Benfotiamine
Diabetes
Nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Benphothiamine
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action