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

NCT05369793 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes (Adult Onset)
  • Diabetic Neuropathies

Interventions

DRUG

Alpha lipoic acid

Administration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months.

DRUG

Roflumilast

Administration of 500 mcg plus vildagliptin/metformin combination(50/1000mg) orally once daily for 3 months.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05369793 on ClinicalTrials.gov