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

Tanta University

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes (Adult Onset)

Diabetic Neuropathies

Treatments

Drug: Alpha lipoic acid

Drug: Roflumilast

Study type

Interventional

Funder types

Other

Identifiers

NCT05369793

35420/4/22

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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).