Benfotiamine in Diabetic Nephropathy

This study has been completed.

Sponsor:

Collaborators:

Isala Klinieken Hospital

Wörwag Pharma GmbH & Co. KG

Predictions Network

Information provided by:

University Medical Centre Groningen

ClinicalTrials.gov Identifier:

NCT00565318

First received: November 28, 2007

Last updated: November 13, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2007

Last Updated Date

November 13, 2009

Start Date ^ICMJE

December 2007

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in urinary excretion of: -β2 microglobulin -Albumin [ Time Frame: 12 weeks ]

Change History

Complete list of historical versions of study NCT00565318 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in urinary excretion of: kidney injury molecule-1 (KIM-1), macrophage inhibiting factor (MIF), monocyte chemo-attractant protein-1 (MCP-1), and other advanced glycation end-products (AGEs). [ Time Frame: 12 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Benfotiamine in Diabetic Nephropathy

Official Title ^ICMJE

A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy

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).

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Nephropathy

Intervention ^ICMJE

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
Drug: Placebo
3x 1 film coated tablet daily. Duration: 12 weeks.

Other Name: Placebo, Wörwag Pharma GmbH & Co. KG

Study Arm (s)

Active Comparator: A
Intervention: Drug: Benfotiamine
Placebo Comparator: B
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00565318

Other Study ID Numbers ^ICMJE

BENFO-1, NL17390.075.07

Has Data Monitoring Committee

Responsible Party

Alaa Alkhalaf, M.D, University Medical Center Groningen

Study Sponsor ^ICMJE

University Medical Centre Groningen

Collaborators ^ICMJE

Isala Klinieken Hospital
Wörwag Pharma GmbH & Co. KG
Predictions Network

Investigators ^ICMJE

Study Director:	G J Navis, MD, PhD	University Medical Centre Groningen
Principal Investigator:	H JG Bilo, MD, PhD	Isala Klinieken Hospital

Information Provided By

University Medical Centre Groningen

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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