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

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).