Clinical trial NCT05369793: Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
Official title: Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes (Adult Onset)
Diabetic Neuropathies
Keywords: diabetes mellitus
diabetic neuropathy
hyperglycemia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Change in fasting blood glucose
timeFrame: baseline and 3 months later
measure: Change in plasma insulin level
timeFrame: baseline and 3 months later
measure: Change in HOMA-IR index
timeFrame: baseline and 3 months later
measure: Change in HOMA-B index
timeFrame: baseline and 3 months later.
measure: Change in HbA1c
timeFrame: baseline and 3 months later
Secondary outcomes:
measure: Changes in TNF-alfa serum level
timeFrame: baseline and 3 months later
measure: Changes in malondialdehyde serum level (MDA)
timeFrame: baseline and 3 months later
measure: Changes in neurotensin serum levels
timeFrame: baseline and 3 months later
measure: Ewing score
timeFrame: baseline and 3 months later
measure: Changes of Michigan Neuropathy Screening Instrument
timeFrame: baseline and 3 months later
measure: Changes of Michigan Neuropathy Screening Instrument(MNSIE)
timeFrame: baseline and 3 months later
measure: Changes of Douleur Neuropathique-4 (DN4) questionnaire (DN4)
timeFrame: baseline and 3 months later
Other outcomes:
measure: Assessment of changes in patients' quality of life
timeFrame: baseline and 3 months later
measure: Major adverse cardiovascular events (MACE)
timeFrame: 3 months
Locations:
city: Tanta
country: Egypt
facility: Asmaa Elshafey Elsharab
Study officials:
References: