The efficacy and safety of extract as an adjuvant in type 2 diabetes mellitus patients ineffectively managed with metformin: a double-blind, randomized, placebo-controlled trial.

BACKGROUND AND AIM

Type 2 diabetes mellitus (T2DM) is one of the major diseases confronting the health care systems. In diabetes mellitus (DM), combined use of oral hypoglycemic medications has been shown to be more effective than metformin (Met) alone in glycemic control. This study determined the effects of (GKB) extract as an adjuvant to Met in patients with uncontrolled T2DM.

SUBJECTS AND METHODS

Sixty T2DM patients were recruited in a randomized, placebo-controlled, double-blinded, and multicenter trial. The patients, currently using Met, were randomly grouped into those treated with either GKB extract (120 mg/day) or placebo (starch, 120 mg/day) for 90 days. Blood glycated hemoglobin (HbA1c), fasting serum glucose, serum insulin, body mass index (BMI), waist circumference (WC), insulin resistance, and visceral adiposity index (VAI) were determined before (baseline) and after 90 days of GKB extract treatment.

RESULTS

GKB extract significantly decreased blood HbA1c (7.7%±1.2% vs baseline 8.6%±1.6%, <0.001), fasting serum glucose (154.7±36.1 mg/dL vs baseline 194.4±66.1 mg/dL, <0.001) and insulin (13.4±7.8 μU/mL vs baseline 18.5±8.9 μU/mL, =0.006) levels, BMI (31.6±5.1 kg/m vs baseline 34.0±6.0 kg/m, <0.001), waist WC (102.6±10.5 cm vs baseline 106.0±10.9 cm, <0.001), and VAI (158.9±67.2 vs baseline 192.0±86.2, =0.007). GKB extract did not negatively impact the liver, kidney, or hematopoietic functions.

CONCLUSION

GKB extract as an adjuvant was effective in improving Met treatment outcomes in T2DM patients. Thus, it is suggested that GKB extract is an effective dietary supplement for the control of DM in humans.