This randomized, double-blind, placebo-controlled clinical study was conducted to evaluate the efficacy and safety of Antox-D supplementation in participants with type 2 diabetes mellitus and associated metabolic abnormalities over a 90-day treatment period. Eligible participants were randomized to receive either Antox-D or placebo along with standard of care, and assessments were performed at predefined study visits including screening, Day 60, and Day 90. Primary and secondary efficacy parameters included glycemic control, insulin resistance markers, metabolic syndrome severity, lipid profile, anthropometric measurements, fatigue severity, and diabetes-related quality of life.

Antox-D supplementation demonstrated significant improvement in glycemic parameters compared with placebo. HbA1c levels decreased significantly from 7.48 ± 0.32% at screening to 6.85 ± 0.36% at Day 90 in the Antox-D group, corresponding to an 8.34% reduction compared with a 2.72% reduction in the placebo group (p = 0.0002). Fasting plasma glucose showed statistically significant between-group differences at Day 60 (p = 0.028) and Day 90 (p = 0.002), while postprandial plasma glucose levels demonstrated greater numerical reduction in the Antox-D group compared with placebo. Significant improvements were also observed in insulin resistance parameters, including reductions in fasting insulin levels and HOMA-IR, with the latter showing a 16.49% decrease in the Antox-D group compared with a 2.77% increase in the placebo group (p = 0.0004).

Participants receiving Antox-D also demonstrated significant improvement in metabolic and clinical outcomes. Metabolic syndrome severity, assessed using MetS Z score, showed a 35.47% reduction in the Antox-D group compared with a 2.43% increase in the placebo group (p = 0.027). Favorable effects on lipid parameters were observed, including a statistically significant reduction in LDL cholesterol (p = 0.0006), along with numerical improvements in total cholesterol, triglycerides, and VLDL cholesterol. Significant reductions in body weight and BMI were also reported in the Antox-D group. Additionally, participants experienced improvement in fatigue severity and diabetes-related quality of life across multiple domains, including treatment satisfaction, diabetes management, exercise, routine diabetes check-ups, and disease-related knowledge.

Antox-D was found to be safe and well tolerated throughout the study duration. No serious adverse events, clinically significant safety concerns, or investigational product-related discontinuations were reported. Serum CRP levels did not show statistically significant changes between groups during the study period. Overall tolerability remained within the “excellent tolerability” category in both treatment groups. Based on the study findings, Antox-D demonstrated clinically meaningful benefits in glycemic control, insulin resistance, metabolic health, and quality of life with a favorable safety and tolerability profile over 90 days of supplementation.