Background Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired glucose regulation. Unequal access to healthcare products, services, and reliable information complicates effective disease management, underscoring the urgent need for affordable, supportive interventions. In this context, adjunctive strategies, i.e., nutraceutical formulations, are gaining interest for their potential to enhance insulin sensitivity and support overall diabetes management. Objective This study aimed to evaluate the safety and efficacy of a nutraceutical formulation in individuals with T2DM. Study determines metabolic parameters such as fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and glycated hemoglobin (HbA1c), levels including quality-of-life (QoL) and diabetes-related symptom management. Methods This prospective, open-label study enrolled male and female participants aged 18-65 years with established T2DM. Participants received two capsules of the formulation daily for 12 weeks in addition to their standard antidiabetic therapy. Data were analysed statistically tools. The study was conducted in accordance with the Declaration of Helsinki (DoH) and International Council for Harmonisation-Good Clinical Practice (ICH-GCP) guidelines, with approval from the Sai Krupa Hospital Institutional Ethics Committee (Ref. No. ECR/1350/Inst/MH/2020; dated June 07, 2024) and registration in the Clinical Trials Registry of India (CTRI). https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTA1NTc4 dated June 06, 2024). Results Thirty participants completed the study without any reported adverse events. At Week 12, significant reductions were observed in HbA1c, FPG, and PPG levels compared with the baseline. Participants also demonstrated significant improvements in QoL scores and a reduction in sugar cravings. Conclusion The findings indicate that the nutraceutical capsule Gymne-Mag D® is safe and leads to an improvement in glycemic control and overall metabolic well-being in individuals with T2DM. By improving insulin sensitivity and reducing sugar cravings, this formulation shows promise as an affordable and well-tolerated adjunct to conventional diabetes management strategies. The datasets analyzed during the current study are available in the Zenodo repository https://doi.org/10.5281/zenodo.20132138 .
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