Efficacy and tolerability of DPP4 inhibitor, teneligliptin, on autonomic and peripheral neuropathy in type 2 diabetes: an open label, pilot study.

Abstract

BACKGROUND:

Diabetic neuropathy increases risk of cardiovascular disease, peripheral artery disease, foot amputation and overall mortality. Not only hyperglycaemia induced nerve damage is harder to repair using currently approved medications, but also, the use of these agents is often limited by the extent of pain relief provided and side effects.

METHODOLOGY:

In this prospective, open-label, pilot study, 20 type-2 diabetes mellitus patients (male/female=13/7, mean age- 56.1±8.04 years), meeting inclusion/exclusion criteria, were treated with dipeptidyl peptidase-4 (DPP-4) inhibitor, Teneligliptin, 20mg once a day for three months. Efficacy parameters: Sudomotor function (Sudoscan score); parasympathetic dysfunction assessed using Ewing's criteria i.e. heart rate response to -standing (HRS), -valsalva (HRV) and -deep breath (HRD); sympathetic dysfunction assessed as blood pressure response to -standing (BPS) and -handgrip (BPH); ankle brachial index (ABI), vibration perception threshold (VPT), C-reactive protein, glycemic profile and health related quality of life (HRQoL); and, tolerability parameters: complete blood count, liver function tests, serum creatinine, thyroid stimulating hormone, QT- interval and serum vitamin B12 levels, were measured.

RESULTS:

There was no statistical difference in BMI, SBP, DBP, HRD, BPH and all safety parameters. After 12 weeks treatment, there was improvement in HRS (p<0.01) and HRV (p<0.01), but not in HRD (p=0.12). BPS was significantly lowered (p <0.01), but not the BPH (p =0.06). Sudoscan score was increased, while VPT was significantly decreased (both p<0.01).

CONCLUSION:

Teneligliptin not only improves the glycemic status but also improves sudomotor function, peripheral and autonomic neuropathy, and reduces vascular inflammation in type 2 diabetes.

• Authors: Ashit Syngle, Simran Chahal, Kanchan Vohra
• Journal: Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology (Neurol Sci) Vol. 42 Issue 4 Pg. 1429-1436 (Apr 2021) ISSN: 1590-3478 [Electronic] Italy
• PMID: 32803534 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
• Dipeptidyl-Peptidase IV Inhibitors
• Pyrazoles
• Thiazolidines
• DPP4 protein, human
• Dipeptidyl Peptidase 4

Topics

• Autonomic Nervous System Diseases
• Diabetes Mellitus, Type 2 (complications, drug therapy)
• Diabetic Neuropathies (drug therapy)
• Dipeptidyl Peptidase 4
• Dipeptidyl-Peptidase IV Inhibitors (therapeutic use)
• Female
• Hand Strength
• Humans
• Male
• Middle Aged
• Pilot Projects
• Prospective Studies
• Pyrazoles
• Quality of Life
• Thiazolidines