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Trial · Interventional

Not yet recruitingPhase 4Registry data

Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

Short name T-DPN

NCTNCT07706088 (opens ClinicalTrials.gov in a new tab)Other id001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
40 participants (estimated)
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Jul 2026 (estimated)
Primary completion
1 Jul 2028 (estimated)
Completion
1 Jul 2028 (estimated)
First posted
15 Jul 2026
Last update posted
15 Jul 2026
Conditions
Neuropathy, Small Fiber · Diabete Mellitus

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 4

    T-DPN

    NCT07706088

    est. Jul 2026 to est. 1 Jul 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Tirzepatide is a dual agonist of GLP-1 Receptor and the GIP receptor, producing substantial improvement in glycaemic control, weight reduction and insulin sensitivity. Beyond its metabolic effects, incretin signalling has demonstrated neuroprotective and neurotropic properties, including activation of intracellular pathways that enhance neuronal survival and regeneration. Using tirzapatide for diabetic sensorimotor peripheral neuropathy and assessing with CCM / NCS and BDNF will represent three complementary aspects of nerve regeneration: metabolic control, structural nerve repair and neurotrophic signalling.

Interventions

  • Tirzepatide 2.5mg weeklyDrug
  • all standard of care to diabetic patient besides tirzepatideDrug

Arms2

  • Experimental

    patients with diabetic peripheral neuropathy to receive standard of care including tirzepatide

    tirzepatide drug being given to diabetic patients with peripheral neuuropathy

  • Active comparator

    diabetic patients recieving standard care without use of tirzepatide

    all standard care except tirzepatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To assess the percent change in CNFD compared to baseline

    Time frame · 6 months

Secondary outcomes(1)

  1. corneal confocal microscopy

    Time frame · 6 months

    Registry description

    To assess the percent change in CNBD ,CNFL compared to baseline To assess change in parameters ( CMAP/ DL / CV for motor nerves) and parameters (SNAP/ DL / CV for sensory nerves ) as assessed by NCS To assess change in body composition , HbA1C , FBS AND PP compared to baseline To assess change in oxidative stress markers SOD and inflammatory markers IL-6 To assess change in peripheral nerve injury marker BDNF.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Eligible participants (≥ 18 years) with diabetes duration of \< 10 years, baseline HbA1c between 7% and 10% Signs and symptoms of DSPN based on a Michigan Neuropathy Screening Instrument (MNSI) history composite score of \>= 7 OR MNSI examination SCORE \>= 2.5 will be enrolled. BMI \>= 27 KG/metre 2. Exclusion Criteria: 1. participants with untreated hypothyroidism 2. history of leprosy 3. peripheral vascular disease defined by ankle-brachial index (ABI) \&lt; 0.9 4. serum B12 levels \< 200 pg./mL/ if low will be supplemented 5. history of alcohol excess (\>=2 and \>= 1 standard drink per day for male and female respectively) 6. any condition affecting corneal nerves (severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months or Sjogren\&#39;s or sicca syndrome 7. use of oral contraceptives.

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