DLBS3233, a combined bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa, in type-2 diabetes mellitus patients inadequately controlled by metformin and other oral antidiabetic agents

Abstract

BackgroundDLBS3233, 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. MethodsThis 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. ConclusionsThe 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.

Medicinal Value of Lagerstroemia Speciosa: An Updated Review

“…DLBS3233 did not adversely affect body weight, liver, and renal function. Most adverse events observed were mild and they all had been resolved by the end of the study [77].…”

Medicinal plants for the treatment of obesity and overweight: A review

“…DLBS3233 did not adversely affect body weight, liver, and renal function. Most adverse events observed were mild and they all had been resolved by the end of the study [58][59].…”

DLBS3233 reduces inflammatory marker on kidney by increasing expression GLUT1 and GLUT2 in diabetic rats

“…6 DLBS3233, an Indonesian herbal product, which is a combined bioactive fraction of Cinnamomum burmanii and Lagerstroaemia speciosa, has demonstrated benefits in glucose control and upregulation of insulin signal transduction. [7][8][9][10][11][12] Studies on Swiss Albino 3T3 pre-adipocytes mice showed that DLBS3233 works by increasing the expression of PI3-kinase, Akt, GLUT-4, peroxisome proliferators-activator receptor (PPAR)-γ, and PPAR-δ, and decreased the expression of the resistin gene at the mRNA level. 12 Previous in vitro studies also reported that DLBS3233 increased GLUT-4 expression leading to increased glucose uptake in insulin-resistant 3T3-Swiss Albino adipocytes.…”