Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in HOMA-B index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/ m
- •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).
Arms & Interventions
Alpha-lipoic acid arm
Administration of alpha-lipoic acid 600 mg orally once daily for 3 months.
Intervention: Alpha lipoic acid (Drug)
Roflumilast arm
Administration of roflumilast 500 mcg orally once daily for 3 months.
Intervention: Roflumilast (Drug)
Outcomes
Primary Outcomes
Change in HOMA-B index
Time Frame: baseline and 3 months later.
HOMA-B will be calculated for all patients at baseline and 3 months later.
Change in fasting blood glucose
Time Frame: baseline and 3 months later
Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values
Change in plasma insulin level
Time Frame: baseline and 3 months later
Subtracting pre-treatment from post-treatment values of plasma insulin
Change in HOMA-IR index
Time Frame: baseline and 3 months later
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Change in HbA1c
Time Frame: baseline and 3 months later
Subtracting pre-treatment from post-treatment values of HbA1C
Secondary Outcomes
- Changes in malondialdehyde serum level (MDA)(baseline and 3 months later)
- Changes in neurotensin serum levels(baseline and 3 months later)
- Changes of Michigan Neuropathy Screening Instrument(MNSIE)(baseline and 3 months later)
- Changes of Douleur Neuropathique-4 (DN4) questionnaire (DN4)(baseline and 3 months later)
- Changes in TNF-alfa serum level(baseline and 3 months later)
- Ewing score(baseline and 3 months later)
- Changes of Michigan Neuropathy Screening Instrument(baseline and 3 months later)
Investigators
Asmaa Elshafey Elsharab
Pharm D
Tanta University