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

Phase 3 Completed 60 enrolled Tanta University

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2022-08-01
Primary completion: 2023-10-10
Completion: 2023-10-10

Publications

Elsharab A, Nooh MZ, Matard RS, Mostafa TM, El-Afify DR. Efficacy and Safety of Roflumilast versus Alpha-Lipoic Acid in Type 2 Diabetes with Neuropathy: A Comparative Clinical Study. Diabetes Metab Syndr Obes. 2025 Nov 13;18:4193-4210. doi: 10.2147/DMSO.S548285. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roflumilast	Small molecule	500 ug	Oral
Comparator	alpha-lipoic acid	Small molecule	600 mg	Oral
Comparator	Metformin	Small molecule	1000 mg	Oral
Comparator	Vildagliptin	Other / unclassified	50 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications