Abstract
Background
DLBS3233, a combined bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa, has preclinically demonstrated its beneficial effects on glucose and lipid metabolism through the upregulation of insulin-signal transduction. This study evaluated the clinical efficacy of an add-on therapy with DLBS3233 in type-2 diabetes mellitus subjects inadequately controlled by metformin and other oral antidiabetes.
Methods
This was an open and prospective clinical study for 12 weeks of therapy, involving type-2 diabetes mellitus patients who had been treated with two oral antidiabetic agents for at least 3 months prior to screening, yet, with HbA1c level was still beyond 7.0 %. DLBS3233 was given orally at the dose of 100 mg once daily in addition to their baseline oral antidiabetes medication. The primary end point was the reduction of HbA1c level; and the secondary end points were changes of fasting and 1-h postprandial glucose, homeostatic model assessment-insulin resistance, adiponectin, and lipid profile, from their respective baseline.
Results
After 12 weeks of treatment, the HbA1c level was reduced by 0.65±1.58 % (p=0.001) from baseline (9.67±2.11 %); while the 1-h-PG level was reduced by –1.45±3.89 mmol/L (p=0.021) from baseline (15.29±4.49 mmol/L). Insulin sensitivity, lipid profile and adiponectin level were improved to a considerable extent. DLBS3233 did not adversely affect body weight, liver, and renal function. Most adverse events observed were tolerably mild and they all had been resolved by the end of the study.
Conclusions
The add-on oral antidiabetes therapy with DLBS3233 at the dose of 100 mg once daily helped type-2 diabetes mellitus patients to improve their glycemic control, enhance insulin sensitivity, lipid profile, and adiponectin level. In addition, DLBS3233 treatment concomitantly with other oral antidiabetic agents was proven safe and tolerable in type-2 diabetes subjects.
Acknowledgments
The authors sincerely thank Dr Jongky Hendro Prayitno, SpPD, Dr Hermina Novida, SpPD, Dr Hermawan, SpPD, Dr Musofa Rusli, SpPD, and Dr M. Miftahussurur, SpPD, for their administrative and technical support in subject recruitment and enrollment; and gratefully acknowledge Liana W. Susanto, MBiomed for her technical assistance in statistical analysis and preparing the manuscript for publication.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission. AT, SM, and RRT provided the study concept and design, interpreted the study data, and critically reviewed the intellectual content of the manuscript. AT led and supervised the study conduct. SM actively involved in the study conduct, recruited, enrolled, and took care of the study subjects and acquired the study data. AT and RRT made the decision to submit the manuscript for publication. All authors have access to the data and assume responsibility for the integrity and completeness of the reported data and to maintain confidentiality of the data.
Clinical trial registry (ClinicalTrials.gov): NCT01472614.
Research funding: The study was supported by PT. Dexa Medica, Indonesia.
Employment or leadership: R.R. Tjandrawinata is employee at PT. Dexa Medica, Indonesia.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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