NCT05369793 is a Phase 3 clinical trial of Alpha lipoic acid in Type 2 Diabetes (Adult Onset), sponsored by Tanta University.

Who is sponsoring NCT05369793?

NCT05369793 is sponsored by Tanta University.

What drugs are being tested in NCT05369793?

Interventions in NCT05369793: Alpha lipoic acid, Roflumilast.

What condition does NCT05369793 study?

NCT05369793 studies Type 2 Diabetes (Adult Onset), Diabetic Neuropathies.

Is NCT05369793 still recruiting?

NCT05369793 is currently completed. Last updated 22 November 2023.

Last reviewed 2023-11-22 · How we verify

NCT05369793

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy

Completed Phase 3 Last updated 22 November 2023

What this trial tests

Phase 3 trial testing Alpha lipoic acid in Type 2 Diabetes (Adult Onset) in 60 participants. Completed in 10 October 2023.

Timeline

1 August 2022

Primary endpoint
10 October 2023

10 October 2023

Quick facts

Lead sponsor	Tanta University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 August 2022
Primary completion	10 October 2023
Estimated completion	10 October 2023
Sites	1 location across Egypt

Drugs / interventions tested

Alpha lipoic acid
Roflumilast (ROFLUMILAST) — full drug profile →

Conditions studied

Type 2 Diabetes (Adult Onset) — all drugs for Type 2 Diabetes (Adult Onset) →
Diabetic Neuropathies — all drugs for Diabetic Neuropathies →

Sponsor

Tanta University

Who can join

Adults 25 to 65, any sex, with Type 2 Diabetes (Adult Onset) or Diabetic Neuropathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin resistance, oxidative and inflammatory markers in Type 2 diabetic patients with diabetic neuropathy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

A Review of Recent Pharmacological Advances in the Management of Diabetes-Associated Peripheral Neuropathy.
Syed O, Jancic P, Knezevic NN. · · 2023 · cited 13× · PMID 37375749 · DOI 10.3390/ph16060801
Innovative strategies for diabetic peripheral neuropathy: From clinical management to emerging bioengineering solutions.
He Z, Diao J, Hamel FG, Duan B. · · 2026 · PMID 41737633 · DOI 10.1016/j.bioactmat.2026.02.023
Efficacy and Safety of Roflumilast versus Alpha-Lipoic Acid in Type 2 Diabetes with Neuropathy: A Comparative Clinical Study.
Elsharab A, Nooh MZ, Matard RS, Mostafa TM, et al · · 2025 · PMID 41256904 · DOI 10.2147/dmso.s548285

Verify or expand the search:

Other trials of Alpha lipoic acid

Trials testing the same drug.

NCT06286098 — Alpha Lipoic Acid in Pediatrics on Hemodialysis · Phase 3 · enrolling by invitation
NCT06418347 — Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females · Phase 3 · unknown
NCT06703593 — Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients · Phase 2 · completed
NCT06131918 — Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy · Phase 2 · completed
NCT04322240 — Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy · NA · completed

Other recruiting trials for Type 2 Diabetes (Adult Onset)

Currently open trials in the same condition.

NCT06246799 — Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes · Phase 3 · recruiting
NCT06000813 — REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults · NA · active not recruiting

Other Tanta University trials

Trials by the same sponsor.

NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients · NA · not yet recruiting
NCT06966856 — This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcti · Phase 3 · not yet recruiting
NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
NCT07498998 — Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome · NA · not yet recruiting
NCT07114250 — Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05369793 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tanta University
Last refreshed: 22 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05369793.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing