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Study of the effectiveness and safety of alpha-lipoic acid and benfotiamine for the treatment of symptoms in patients with diabetic neuropathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Diabetic sensorimotor polyneuropathy, a condition involving nerve damage caused by diabetes that typically results in symptoms like pain, numbness, or tingling in the hands and feet. The purpose of the study is to evaluate the effectiveness and safety of a combined treatment compared to using single medications alone. Participants will receive one of three different treatment options consisting of benfotiamine, thioctic acid, or a combination of both substances.

The study involves the use of benfotiamine, which is taken as an oral tablet, and thioctic acid, also known as alpha-lipoic acid. One group will take the combination of these two substances, while other groups will take the individual medications to compare their effects. The medications used for comparison include Benfogamma Forte and Thiogamma.

During the study, individuals will follow a treatment plan for a period of 16 weeks. The process is designed to be double-blind, meaning that neither the participants nor the researchers know which specific treatment is being administered to each person. This helps to ensure that the results are objective and not influenced by expectations.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>treatment phase</b>
The treatment period lasts for a total of 16 weeks.
One of three different medication groups is assigned. because this is a double-blind study, neither the participant nor the doctor knows which specific medicine is being used.
The possible medications include benfotiamine (a form of vitamin B1) or thioctic acid (also known as alpha-lipoic acid), which is used to treat symptoms of diabetic sensorimotor polyneuropathy, a condition involving nerve damage caused by diabetes.
The comparator groups involve taking benfogamma forte (300 mg of benfotiamine) or thiogamma (600 mg of thioctic acid) via oral tablets.
A double-dummy method is used, meaning tablets that look like the assigned medication and tablets that look like the other medications are taken to ensure the blinded nature of the study is maintained.
Step 2
<b>monitoring and assessments</b>
symptom changes are tracked at specific intervals, including on days 27, 28, 55, 56, 83, 84, 111, and 112.
neurological assessments are performed to check nerve conduction velocity (the speed at which signals travel through nerves) and nerve action potential amplitude (the strength of the electrical signal in the nerve) up to day 112.
disability and symptom scores, such as the neuropathy disability score and the neuropathy total symptom score, are recorded at various stages to measure the impact on symptoms.
pain levels are measured using a numerical rating scale on day 56 and day 112.
vital signs, including heart rate and seated blood pressure, are measured on day 56 and day 112.
quality of life and overall impression of change are evaluated on days 56, 112, and 126.
safety checks involve monitoring blood parameters and recording any adverse events, which are any unwanted medical occurrences that happen during the study.

Who can join the trial?

16 criteria

You must provide written informed consent, which means signing a document that states you understand the study and agree to take part before any tests begin.
You must have a diagnosis of mild to moderate diabetic sensorimotor polyneuropathy (DSPN), which is nerve damage caused by diabetes that affects how you feel sensations in your body.
Your nerve tests must show issues with the sural nerve, which is a specific nerve in the lower leg that carries sensation.
You must have specific nerve symptoms and signs, measured by specialized questionnaires called NTSS-6 and NDS.
Your HbA1c level, which is a blood test that shows your average blood sugar levels over the past few months, must be 9.5% or lower.
You must be willing to avoid changing your diet or lifestyle, such as starting new weight-loss medications, during the study.
You must be able to complete a baseline symptom assessment, which is a record of your symptoms, for seven days in a row using a digital link.
You must be able to follow the rules and restrictions of the study.
You must be able to travel to the study site for your scheduled appointments.
You must have a way to receive SMS, which are text messages on a mobile phone.
You must be 18 years of age or older.
You must have been diagnosed with type 1 or type 2 diabetes at least one year before the study begins.
Your diabetes medications or insulin doses must be stable, meaning they have not changed significantly in the last 3 months.
If you take SGLT-2 inhibitors (a type of diabetes medication), you must have been taking them for at least 26 weeks.
Your blood sugar metabolism must be stable, meaning you have not had serious complications like hypoglycaemia (dangerously low blood sugar causing unconsciousness), hyperosmolar hyperglycemic state (extremely high blood sugar), or ketoacidosis (a serious buildup of acids in the blood) in the last 3 months.
You must have persistent or recurrent neuropathic symptoms, such as numbness, tingling, burning, or stabbing pain, that have occurred within the last 3 months.

Who cannot join the trial?

26 criteria

Women who could become pregnant and are not using a reliable birth control method (such as birth control pills, an intrauterine device, or using condoms) for at least 2 months before joining the study.
Use of GLP-RA (a type of medication used to manage blood sugar) within the last 12 months.
Use of any pain medication for chronic pain within the last 2 months, except for specific allowed doses of gabapentin, pregabalin, or duloxetine that have not changed recently.
Taking pain relief like ibuprofen or paracetamol for more than 7 days in a row, or using low-dose aspirin for blood thinning.
Having any allergy or known sensitivity to the medications used in the study.
Significant liver disease, which is measured by high levels of certain enzymes (AST or ALT) in the blood.
Significant kidney disease, measured by a low eGFR (a value that shows how well your kidneys filter waste from your blood).
Uncontrolled high blood pressure (hypertension), where the top number is higher than 160 or the bottom number is higher than 100.
Having a major heart attack (myocardial infarction), a stroke, or cancer (malignant disease) within the last 12 months.
Having severe or unstable depression or other mental health conditions that could affect the study results.
Currently taking antidepressants, unless it is a stable dose of duloxetine or selective serotonin reuptake inhibitors (a common type of antidepressant).
Having any other medical condition that the doctor believes might interfere with the study measurements.
Having nerve damage (neuropathy) caused by something other than diabetes, such as vitamin B12 deficiency, chemotherapy, or autoimmune issues (where the body attacks itself).
Having muscle disease (myopathy) or other nervous system diseases.
Current or past alcohol abuse, defined as drinking more than 24 units a week for men or 12 units a week for women.
Current or past regular use of recreational drugs, except for occasional or experimental use of cannabis without signs of addiction.
Taking part in another clinical trial (medical research study) within the last 2 months.
Living in the same house as someone else who is also participating in this study.
Being pregnant or breastfeeding at the time of screening.
Having severe chronic pain from a cause other than diabetes, such as fibromyalgia (a condition causing widespread muscle pain).
Having both legs amputated above the ankle.
Having a history of heart, lung, stomach, blood, or hormone diseases, or cancer, that could cause nerve pain or symptoms.
Having a very high pain level (higher than a 9 out of 10) on a NRS (a scale used to measure how much pain you feel) during the last 4 weeks.
Having a magnesium deficiency that cannot be corrected before starting the study.
Taking supplements such as B-vitamins, antioxidants, or evening primrose oil for 5 days or longer within the last 2 months.
Using electrical nerve stimulation, muscle stimulation, or capsaicin patches (heat-based pain patches) within the last 2 months.

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Verified sites

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Verified
Gyongyosi Bugat Pal Korhaz
Gyongyos, Hungary
Responsive
Semmelweis University
Budapest, Hungary
Verified
University Of Debrecen
Debrecen, Hungary

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Investigated drugs

Benfotiamine
is a form of vitamin B1 that is being tested to see how well it helps treat the symptoms of nerve damage caused by diabetes.
Alpha-lipoic acid
is an antioxidant used in this study to help manage the symptoms associated with diabetic nerve damage.

Benfotiamine

What is already known about the treatment

Benfotiamine
This medication is taken as a film-coated tablet by mouth. It is a specialized form of vitamin B1 that is widely used in medical literature to help manage complications from high blood sugar. It works at a cellular level by activating specific enzymes that prevent harmful sugar-related processes from damaging nerves. This substance is classified as a vitamin derivative used to support nerve health.
Thioctic acid
This substance is administered orally in the form of a film-coated tablet. It is a well-known antioxidant used in medicine to help treat nerve damage caused by diabetes. It works by neutralizing harmful molecules in the body and helping to improve energy production within nerve cells. It is pharmacologically classified as an antioxidant and metabolic cofactor.

Investigated diseases

Diabetic sensorimotor polyneuropathy - This condition is a type of nerve damage that occurs as a complication of diabetes. It primarily affects the peripheral nerves, which are responsible for carrying signals between the body and the brain. The damage typically begins in the longest nerves, often starting in the feet. Over time, it can spread to the hands and legs. This progression causes changes in how people feel sensations or move their limbs.