Status:
COMPLETED
Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
Lead Sponsor:
Tanta University
Conditions:
Type 2 Diabetes (Adult Onset)
Diabetic Neuropathies
Eligibility:
All Genders
25-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05369793
Start Date
August 1 2022
End Date
October 10 2023
Last Update
November 22 2023
Active Locations (1)
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1
Asmaa Elshafey Elsharab
Tanta, Egypt, 31511