Diabetes Mellitus, Type 1Phase 1/2NCT00117026
Effects of Vitamin B1 in Type 1 Diabetic Patients
A Phase 1/2 study testing Benfotiamine in people with Diabetes Mellitus, Type 1, run by University Hospital, Aker at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Benfotiamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2005to Feb 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes (of at least 15 years duration) as assessed by medical history.
Who cannot join
- Macroalbuminuria
- Symptomatic gastroparesis. Diabetic nephropathy with a creatinine clearance less than 60 cc/min.
- Evidence of chronic infection.
- History of any malignancy.
- Any chronic medical condition that unduly increases the risk for the potential enrollee as judged by study investigators.
- Pregnancy, breastfeeding or planned pregnancy within two years.
- Supplementation with thiamine > 2mg per day and/or alpha-lipoic acid
- Chronic alcoholism/alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?
The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.
Read the detailed description
Despite intensive strategies designed to achieve good metabolic control, diabetic patients are still at a markedly increased risk of eye and kidney disease, nerve damage, limb amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. It has recently been shown that supplementation with lipid soluble vitamin B1 (benfotiamine) in diabetic rats could effectively block three major biochemical pathways of hyperglycemic damage. It has also been shown that supplementation prevented the development of experimental diabetic retinopathy and nephropathy, without changes in glycemic control. However, the applicability of the above findings to humans is unknown, and the diabetic late complications in experimental animals do not in every aspect mirror the human diabetic complications.
This project will allow us to evaluate the potential of benfotiamine to reduce or prevent the further development of microvascular disease in type 1 diabetics.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Placebo, Benfotiamine
- Keywords
- Diabetes Complications, benfotiamine, type 1 diabetes, elevated urinary albumin excretion, nerve function, advanced glycation end products
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo for benfotiamine
BenfotiamineDrug
Also called S-benzoylthiamine O-monophoshate
300mg/day
| Study group | Role | What they receive |
|---|---|---|
| Benfotiamine | Experimental | Benfotiamine 300mg/day Receives: Drug: Benfotiamine |
| Placebo | Placebo comparator | Placebo for benfotiamine Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-limb nerve conduction velocity
Measured: 24 months
Secondary outcomes (1)
Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aker
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Kristian F. Hanssen, Oslo University Hospital
- Investigators
- Kristian F Hanssen, MD, PhD, Principal investigator, University Hospital, Aker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117026
- Sponsor's protocol ID
- AkerU
- Status last verified
- May 2013
- First submitted
- 30 Jun 2005
- Last updated
- 10 May 2013
- Results posted
- No
Publications
Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. doi: 10.2337/dc11-1895. Epub 2012 Mar 23.
PubMed 22446172
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes?
- ClinicalTrials.gov ID
- NCT00117026
- Acronym / sponsor ID
- AkerU
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Complications, benfotiamine, type 1 diabetes, elevated urinary albumin excretion, nerve function, advanced glycation end products
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, AkerUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Aug 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.
Detailed description
Despite intensive strategies designed to achieve good metabolic control, diabetic patients are still at a markedly increased risk of eye and kidney disease, nerve damage, limb amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. It has recently been shown that supplementation with lipid soluble vitamin B1 (benfotiamine) in diabetic rats could effectively block three major biochemical pathways of hyperglycemic damage. It has also been shown that supplementation prevented the development of experimental diabetic retinopathy and nephropathy, without changes in glycemic control. However, the applicability of the above findings to humans is unknown, and the diabetic late complications in experimental animals do not in every aspect mirror the human diabetic complications.
This project will allow us to evaluate the potential of benfotiamine to reduce or prevent the further development of microvascular disease in type 1 diabetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benfotiamine | Experimental | Drug: BenfotiamineBenfotiamine 300mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for benfotiamine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Type 1 diabetes (of at least 15 years duration) as assessed by medical history.
Key exclusion criteria (8 listed)
- Macroalbuminuria
- Symptomatic gastroparesis. Diabetic nephropathy with a creatinine clearance less than 60 cc/min.
- Evidence of chronic infection.
- History of any malignancy.
- Any chronic medical condition that unduly increases the risk for the potential enrollee as judged by study investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo for benfotiamine | Drug | Placebo |
| BenfotiamineAlso: S-benzoylthiamine O-monophoshate300mg/day | Drug | Benfotiamine |
Primary outcome
Lower-limb nerve conduction velocity
Time frame: 24 months
1 secondary outcome
Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Derived from this study: PubMed 22446172Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. doi: 10.2337/dc11-1895. Epub 2012 Mar 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian F Hanssen, MD, PhD principal investigator
University Hospital, Aker
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Benfotiamine in people with Diabetes Mellitus, Type 1, run by University Hospital, Aker at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower-limb nerve conduction velocity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00117026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.