AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy and safety of a combined therapy with Alpha-Lipoic Acid and Benfotiamine in the symptomatic treatment of diabetic sensorimotor polyneuropathy - a prospective, randomized, controlled, parallel group, double-blind, double-dummy 3-arm trial

This research study is looking into a new treatment for nerve damage, called diabetic sensorimotor polyneuropathy, which can happen to people with diabetes. The study will test a combination of two medicines: alpha-lipoic acid and benfotiamine. We want to find out if this combined treatment can reduce symptoms like pain or numbness, and if it's safe for patients to take. This is an early-stage study, meaning it's one of the first times this combination is being carefully tested in people. Participants will be taking different treatments, and neither they nor their doctors will know who is getting which treatment, to ensure fair results. The study aims to look at how participants' symptoms change over about four months.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Woerwag Pharma GmbH & Co. KG

Enrolment target

136

Start

18 Feb 2026

Diabetic sensorimotor polyneuropathy (DSPN)

What is this study about?

This study is trying to find better ways to help people who have nerve damage because of diabetes. This condition, called diabetic sensorimotor polyneuropathy (DSPN), can cause uncomfortable symptoms like pain, tingling, or numbness, mostly in the feet and hands. The researchers are particularly interested in a combination of two specific medicines: alpha-lipoic acid (known in some pharmacies as Thiogamma) and benfotiamine (known as Benfogamma Forte).

The main goal of this study is to see if this combined treatment can improve these nerve symptoms over about four months and if it's safe to use. To make sure the results are fair, some participants will receive one medicine, some the other, and some a combination, but no one involved in the study – not the patients, nor the doctors – will know who is getting what until the study is over. This is called a 'double-blind' study. Researchers will closely monitor changes in symptoms, how your nerves are working, and your overall well-being throughout the study.

By taking part, you could help doctors understand if this combination of medicines is a good treatment option for nerve damage associated with diabetes in the future. It's important to remember that this is a research study, and we are still learning about how well and safely these treatments work together.

Key takeaways

This study evaluates two medicines for nerve damage from diabetes.
It aims to see if the combination of medicines improves symptoms and is safe.
Participants will take tablets and attend regular clinic visits for about four months.
It's a 'blinded' study, so you won't know which treatment you are getting.
It's an early-stage research study to gather more information.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, individuals must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to participate if they meet all the other requirements.

Both men and women are eligible to join this research study. The study aims to include a mix of participants to ensure the results can apply to a wide range of people with nerve damage from diabetes.

Beyond age and sex, there will be other specific health requirements that your doctor will discuss with you to make sure the study is a good fit for your individual health situation. These might include details about your diabetes and the specific nerve damage you have.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have nerve damage (neuropathy) caused by diabetes?
Are you able to attend regular clinic appointments for about four months?
Are you willing to take study medication as directed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit where doctors check if you meet all the requirements. Over about four months (112 days), you would regularly take the study medication, possibly more than once a day, as instructed. You would also have several scheduled visits to the clinic for assessments. These visits, typically occurring at various points over the 112 days, would involve doctors checking your symptoms, doing blood tests, taking your blood pressure, and performing simple tests to see how your nerves are working. There might also be follow-up calls or visits after the main treatment period. The total duration of your participation, including screening and follow-up, would be around four and a half months.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combined treatment helps improve your nerve damage symptoms. However, as with any medication, there's always a possibility of side effects, which the study doctors will explain to you. Your health and safety will be carefully monitored throughout the study. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary

Common questions

What is diabetic sensorimotor polyneuropathy?

It's a type of nerve damage that can happen to people with diabetes, often causing pain, numbness, or tingling, usually in the feet and hands.

What are alpha-lipoic acid and benfotiamine?

They are types of vitamins or vitamin-like substances being tested to see if they can help improve nerve health and symptoms.

Will I know if I'm getting the actual treatment?

No, neither you nor your doctor will know which treatment you are receiving until the study is finished. This helps make the study fair.

How long does the study last?

The main treatment part of the study lasts for about four months (112 days), with some follow-up after that.

What is a 'Phase II' study?

It means it's an early-stage study, looking closely at how well a treatment works and if it's safe, after initial safety tests.