A randomized, double-blind, parallel-arm clinical trial to assess the bioavailable efficacy of LipokonTM Berberine and Berberine extract in patients with type 2 diabetes mellitus.

Praful Patil; Saraswati Gupta; Hiral Panchal; Ajay Pathak; Vedant Gupta; Ramshyam Agarwal

doi:10.63363/aijfr.2026.v07i01.3048

A randomized, double-blind, parallel-arm clinical trial to assess the bioavailable efficacy of LipokonTM Berberine and Berberine extract in patients with type 2 diabetes mellitus.

Author(s)	Dr. Praful Patil, Dr. Saraswati Gupta, Mr. Hiral Panchal, Mr. Ajay Pathak, Mr. Vedant Gupta, Dr. Ramshyam Agarwal
Country	India
Abstract	Background: Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and hyperglycemia, leading to various complications affecting organ systems. Berberine, a plant-derived alkaloid, has shown promising effects in improving glycemic control and insulin sensitivity. This Phase 2 clinical trial evaluated the safety and efficacy of LipokonTM Berberine and Berberine extract as an adjunct to oral hypoglycemic agents (OHAs). Methods: In this double-blind, parallel-arm clinical trial, participants were randomized equally to receive the berberine extract. Primary endpoints included fasting plasma glucose (FPG), post-meal plasma glucose (PPG), HbA1c, fasting insulin, and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary endpoints included lipid profile, Metabolic Syndrome Severity Z-score (MetS-Z), anthropometric parameters, and diabetes-related quality of life score (DQOL). Assessments included adverse events (AEs), vital signs, tolerability, and compliance. Result: Both the treatment groups showed significant reductions in FPG, PPG, and HbA1c levels. Decrease in levels of HOMA-IR was comparable in Standard Berberine and LipokonTM Berberine (65.75 % vs 64.45%). Lipid parameters, MetS-Z scores, and anthropometric measures improved in both groups, accompanied by 36-37% improvement in DQOL scores. No serious AEs occurred; all events were mild, self-limiting, and unrelated to the investigational product. Conclusion: LipokonTM Berberine demonstrated clinically meaningful improvements in glycemic control, insulin resistance, lipid metabolism, metabolic syndrome severity, and quality of life, with good safety and tolerability. The formulation may serve as a potential adjuvant to oral hypoglycemic agents (OHA).
Keywords	Type 2 diabetes mellitus; Herbal formulation; Metabolic syndrome, LipokonTM Berberine
Field	Medical / Pharmacy
Published In	Volume 7, Issue 1, January-February 2026
Published On	2026-01-23
DOI	https://doi.org/10.63363/aijfr.2026.v07i01.3048
Short DOI	https://doi.org/hbk6x7

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A randomized, double-blind, parallel-arm clinical trial to assess the bioavailable efficacy of LipokonTM Berberine and Berberine extract in patients with type 2 diabetes mellitus.

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