Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With… (NCT05369793) | Clinical Trial Compass
CompletedPhase 3
Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
Egypt60 participantsStarted 2022-08-01
Plain-language 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.
Who can participate
Age range25 Years – 65 Years
SexALL
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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, p…