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

NCT05369793 | Completed Phase 3 DMC

• 1 other identifier: 35420/4/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetes mellitus; diabetic neuropathy; hyperglycemia

Outcome Measures

Primary Outcomes (5)

• Change in fasting blood glucose

  Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values

  baseline and 3 months later

• Change in plasma insulin level

  Subtracting pre-treatment from post-treatment values of plasma insulin

  baseline and 3 months later

• Change in HOMA-IR index

  HOMA-IR will be calculated for all patients at baseline and 3 months later.

  baseline and 3 months later

• Change in HOMA-B index

  HOMA-B will be calculated for all patients at baseline and 3 months later.

  baseline and 3 months later.

• Change in HbA1c

  Subtracting pre-treatment from post-treatment values of HbA1C

  baseline and 3 months later

Secondary Outcomes (7)

• Changes in TNF-alfa serum level

  baseline and 3 months later

• Changes in malondialdehyde serum level (MDA)

  baseline and 3 months later

• Changes in neurotensin serum levels

  baseline and 3 months later

• Ewing score

  baseline and 3 months later

• Changes of Michigan Neuropathy Screening Instrument

  baseline and 3 months later

Other Outcomes (2)

• Assessment of changes in patients' quality of life

  baseline and 3 months later

• Major adverse cardiovascular events (MACE)

  3 months

Study Arms (2)

Alpha-lipoic acid arm

ACTIVE COMPARATOR

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

Drug: Alpha lipoic acid

Roflumilast arm

EXPERIMENTAL

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

Drug: Roflumilast

Interventions

Alpha lipoic acid DRUG

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

Alpha-lipoic acid arm

Roflumilast DRUG

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

Roflumilast arm

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Asmaa Elshafey Elsharab

Tanta, 31511, Egypt

Location

Related Publications (1)

• 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.

  PMID: 41256904 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies; Diabetes Mellitus; Hyperglycemia

Interventions

Thioctic Acid; Roflumilast

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm D

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: August 1, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)