Insulin sensitizer in prediabetes: a clinical study with DLBS3233, a combined bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa

Abstract

Background

The aim of this paper is to evaluate the efficacy and safety of DLBS3233, a novel bioactive fraction derived from Cinnamomum burmanii and Lagerstroemia speciosa, in improving insulin resistance and preserving β-cell performance in patients with impaired glucose tolerance (IGT).

Patients and methods

Eighty adult subjects with IGT, defined as 2-hour postprandial glucose level of 140–199 mg/dL, were enrolled in this two-arm, 12-week, double-blind, randomized, placebo-controlled preliminary study. Eligible subjects were randomly allocated to receive either DLBS3233 at a dose of 50–100 mg daily or placebo for 12 weeks. The study mainly assessed the improvement of homeostatic model-assessed insulin resistance (HOMA-IR), the 15-minute and 2-hour plasma insulin levels, and the oral disposition index.

Results

After 12 weeks, DLBS3233 improved insulin resistance better than placebo as reflected by a reduced HOMA-IR (−27.04%±29.41% vs −4.90%±41.27%, P=0.013). The improvement of the first- and second-phase insulin secretion was consistently greater in DLBS3233 group than placebo group (−144.78±194.06 vs −71.21±157.19, P=0.022, and −455.03±487.56 vs −269.49±467.77, P=0.033, respectively). Further, DLBS3233 also significantly better improved oral disposition index than placebo. No serious hypoglycemia, edema, or cardiovascular-related adverse events were found in either groups.

Conclusion

This study has shown that DLBS3233 at the dose of 50–100 mg once daily was well tolerated, and promisingly efficacious in improving insulin sensitivity as well as preserving β-cell performance in subjects with IGT.

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Keywords:

• β-cell function
• Cinnamomum burmanii
• DLBS3233
• Lagerstroemia speciosa
• impaired glucose tolerance
• insulin resistance

Acknowledgments

This work was funded by Dexa Medica. The authors express their deepest gratitude to the study subjects who participated in the study. They also gratefully appreciate the assistance of Liana W Susanto, MBiomed, Dexa Medica, in the data analysis as well as in the preparation of the draft manuscript.

Authors contributions

All authors contributed toward data analysis, drafting and critically revising the paper and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.