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

Sponsor
Tanta University
Study ID
NCT05369793
Phase
PHASE3
Status
Completed

Conditions

  • Diabetic Neuropathies
  • Type 2 Diabetes (Adult Onset)

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Alpha lipoic acid — DRUG
    Administration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months.
  • Roflumilast — DRUG
    Administration of 500 mcg plus vildagliptin/metformin combination(50/1000mg) orally once daily for 3 months.

Study Details

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.

Key Dates

Start date
Aug 1, 2022
Status verified
Nov 2023
Primary completion
Oct 10, 2023
Completion
Oct 10, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Alpha-lipoic acid arm
    Administration of alpha-lipoic acid 600 mg orally once daily for 3 months.
  • Experimental: Roflumilast arm
    Administration of roflumilast 500 mcg orally once daily for 3 months.

Primary Outcome Measure

Change in fasting blood glucose [ Time Frame: baseline and 3 months later ]

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