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

NCT ID: NCT05369793

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes (Adult Onset) Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alpha-lipoic acid arm

Administration of alpha-lipoic acid 600 mg orally once daily for 3 months.

Group Type ACTIVE_COMPARATOR

Alpha lipoic acid

Intervention Type DRUG

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

Roflumilast arm

Administration of roflumilast 500 mcg orally once daily for 3 months.

Group Type EXPERIMENTAL

Roflumilast

Intervention Type DRUG

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

Interventions

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Alpha lipoic acid

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

Intervention Type DRUG

Roflumilast

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of type 2 diabetes mellitus (T2DM).
* HbA1c at baseline: ≥7.5 % to 8.5 %.
* BMI between ≥26 and ≤35 kg/ m2.
* Established Diabetic neuropathy diagnosed by nerve conduction study (NCS).

Exclusion Criteria

* Patients diagnosed with type 1 diabetes mellitus or diabetes secondary to pancreatitis or resection of the pancreas.
* Patients diagnosed with hemoglobinopathies, hemolytic anemia, or other diseases which interfere with HbA1c measurement.
* Thyroid disease, cardiovascular disease, peripheral vascular disease, coagulopathy, moderate to severe liver disease (bilirubin\>1.5mg), or renal excretion ≤90ml/min.
* Patients on medications which can result in a change of weight (orlistat, metformin, clozapine, gabapentin) and patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, non-selective β-blockers, thiazides, etc.)
* Treatment with any diabetes medications other than glimepiride prior to intervention.
* Clinically significant cardiac abnormalities (diagnosed clinically, history, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation.
* Patients with morbid obesity (BMI ≥ 40 kg/ m2).
* History or current diagnosis of major depressive disorders or other psychiatric disorders.
* Pregnant and breastfeeding women.
* Patients with any inflammatory diseases.
* Patients on cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, etc.).
* Patients with Low vitamin B12 levels according to suggested normal values for T2DM patients over 60 years old (\<400 pmol/L).
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Elshafey Elsharab

Pharm D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asmaa Elshafey Elsharab

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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35420/4/22

Identifier Type: -

Identifier Source: org_study_id