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Taking peoplePhase 2/3

Nebivolol for nerve damage in people with diabetes

Tests nebivolol in people with diabetic peripheral neuropathy, compared with other treatments.

Key facts

Who runs it
St. John's Research Institute
Where
India2 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.
Status
Recruiting
Phase
Phase 2/3
People taking part
120 people, planned
Started
15 Nov 2024
Planned end
30 Mar 2026
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Nebivolol+ Standard care arm
  • Epalrestat + Alpha Lipoic Acid +Standard care
  • Standard care alone
Record updated
4 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with diabetes who have nerve damage in the feet and legs (diabetic peripheral neuropathy).

Age
18 years or older in the criteria. The record also lists a maximum age of 18 Years.
Sex
All sexes can join.
Disease stage
Diabetes diagnosed 5 years ago or less. HbA1c below 9 at enrolment, with stable blood sugar control for the last three months. Neuropathy shown by an abnormal nerve test (nerve conduction study) plus a symptom or sign: a diabetic neuropathy symptom score of 1/4 or more, or a neuropathy disability score of 3/10 or more.
Biomarker or test result
HbA1c below 9. Abnormal nerve conduction study, with one or more abnormal results in two or more nerves.

Main reasons for not taking part

  • Heart rhythm problems that rule out nebivolol: sick-sinus syndrome, resting heart rate below 50/minute, second or third degree AV-nodal blocks, fascicular blocks
  • Severe asthma or COPD, or acute heart failure
  • A strong need for a non-dihydropyridine calcium channel blocker
  • A strong need for another beta-blocker, as judged by the treating team
  • Major amputation of the legs, done or planned

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Patients aged >= 18 years diagnosed with diabetes mellitus, of a duration of <= 5 years since their diagnosis
  • HbA1c < 9 at enrolment with stable glycemic control for the last three months
  • Neuropathy meeting the following 'Toronto criteria' (8) - (a) abnormal nerve conduction study* based on age-matched controls at the site and - (b) a symptom or sign of neuropathy defined as one of either a diabetic neuropathy symptom score of >= 1/4 Or neuropathy disability score of >= 3/10 (9); Abnormal NCS defined as one or more abnormal Z score in two or more nerves, based on sural nerve amplitude (antidromic stimulation), tibial and peroneal NCV, tibial amplitude, increased F-wave minimum latency (F-min), and absent F-waves (only considered abnormal in tibial nerve)

Who cannot take part

  • Absolute contra-indications for nebivolol - sick-sinus syndrome, sinus bradycardia with a resting heart rate < 50/ minute, second or third degree AV-nodal blocks fascicular blocks, severe asthma or COPD and acute heart failure
  • Patients with a compelling indication for a non-dihydropyridine calcium channel blocker (CCB)
  • Patients with compelling need for another beta-blocker in the judgement of the treating team; Patients who have undergone major amputations of the lower limbs or are posted for the same

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The goal of this clinical trial is to test in patients with diabetic neuropathy,

Read full original descriptionShow less

* Can Nevibolol at a dose of 2.5 mg- 10 mg compared with standard pain modulating treatment conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up. * Can Nevibolol at a dose of 2.5 mg- 10 mg compared with a combination of Alpha Lipoic Acid (600 mg/day)+EPALRESTAT (150 mg/day) conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up

* All potential participants will undergo screening- about 10 ml of blood will be drawn to perform the following assesments at screening- HbA1c, FBS,Vit B12, TSH, fT4. * Baseline assessments conducting a nerve conduction study, quality of life assesment using Eq-5D-5L and NRS pain score. * 20% of patients (24 patients) will undergo Sudoscan, Corneal confocal microscopy and a skin biopsy for assessing IENFD (Intra Epidermal Nerve Fibre Density). * 15th day, 1 month and 3rd month followup for evaluating patients status and medication adherance. * 6th month followup for evaluating patients status and medication adherance.

Researchers will compare Nebivolol against combination of Epalrestat+Alpha Lipoic Acid against standard pain modulating treatment to evaluate their diseaes modifying effect as reflected by nerve conduction study parameters.

The 3 groups in the trial

  • Nebivolol+ Standard care armTreatment being tested

    This arm will receive tablet Nebivolol 2.5 mg OD uptitrated at 2 weeks to 5 mg and at 4 weeks if well tolerated to 10 mg/day which the participant will continue upto week 24

  • Epalrestat + Alpha Lipoic Acid +Standard careExisting treatment, for comparison

    This arm will receive tablet Epalrestat -150mg OD+ cap Alpha Lipoic Acid 600mg OD for 24 weeks.

  • Standard care aloneExisting treatment, for comparison

    Patients in this arm will receive standard care as judged by their treating physicians which is generally pain modifying treatment.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A 3-arm, Open-label, Stratified Randomized Controlled Trial With Blinded End-point Assessment to EValuate A Nitric oxidE Generator (Nebivolol) as a diSease Modifying mediCatioN in Diabetic Peripheral Neuropathy
Plain-language title
Nebivolol for nerve damage in people with diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
4 February 2025