Efficacy and Safety of Roflumilast versus Alpha-Lipoic Acid in Type 2 Diabetes with Neuropathy: A Comparative Clinical Study

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Aim: We aimed to evaluate the efficacy and safety of roflumilast compared to alpha-lipoic acid (ALA) in type 2 diabetic patients with diabetic neuropathy. Methods: In this randomized controlled parallel study, 58 type 2 diabetic patients with diabetic neuropathy were randomly allocated into (Roflumilast group; n=29), which received 500 mcg/day of oral roflumilast and (ALA group; n=29), which received 600 mg/day of oral ALA. At baseline and 12 weeks after intervention, blood samples were collected to assess fasting blood glucose (FBG), glycated hemoglobin (HbA1C), insulin, tumor necrosis factor-α (TNF-α), malondialdehyde (MDA), and neurotensin (NT) levels. Homeostatic Model Assessment of Beta Cell Function (HOMA-1β) and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) were calculated. Neuropathic symptoms and neuropathic pain were assessed using the Michigan Neuropathy Screening Instrument Questionnaire (MNSIQ), the Michigan Neuropathy Screening Instrument Examination (MNSIE), and the Douleur Neuropathique-4 (DN4) questionnaire. Results: After intervention and as compared to baseline, both groups showed significant decreases in HbA1C, FBG, fasting insulin level, HOMA-IR, HOMA-1β, and serum levels of TNF-α, MDA, and neurotensin (P<0.001). The comparison between the two study groups post-treatment indicated that the roflumilast group showed a significant decrease in HbA1C by 0.7% (8.8% relative reduction) compared to 0.3% (3.8% relative reduction) in the ALA group (P<0.001), FBG (P<0.001), fasting insulin level (P=0.012), and HOMA-IR (P<0.001). Similarly, serum MDA level was declined by 0.80 nmol/mL (37.0% reduction) with the roflumilast group versus 0.56 nmol/mL (25.1% reduction) with the ALA group (P=0.003). Post-intervention and compared to baseline data, both groups exhibited significant reductions in neuropathy scores (P<0.001). The comparison between the two study groups after treatment revealed non-significant variations between both groups regarding MNSIQ, MNSIE, and DN4 scores (P>0.05). Conclusion: Roflumilast may offer superior glycemic and oxidative stress control benefits, though neuropathy symptoms control was comparable to ALA. Clinicaltrialsgov Id: (NCT05369793).

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