HC-N2, an active ingredient from ethanol extracts of a Chinese herbal medicine Hedychium coronarium Koenig (Zingiberaceae), has demonstrated excellent efficacy and safety profiles in diabetic animal models. Four weeks treatment with HC-N2 at 60 mg/kg significantly reduced fasting blood glucose and OGTT incremental glucose AUC by 43% (p<0.01) and 62% (p<0.001); respectively. In addition, preclinical repeat-dose toxicity study in rat and in dog both revealed NOAEL to be 972 mg/kg/day which provided a safety margin of 10 folds over the maximal recommended starting dose in phase 1 clinical study.
VN-B101, a 500 mg tablet contains 165mg active ingredient HC-N2 with 335 mg of inactive excipients, would be used in the clinical trials. The clinical study protocol of VN-B101 tablet received the IND approval from USFDA and TFDA in 2012 and 2016; respectively.
One of the major objectives of this study was to evaluate effects of VN-B101 as an adjuvant to metformin (MET) in patients with uncontrolled type 2 diabetes mellitus (T2DM). This trial was a single center, open-label, phase-I study (NCT03033433) consisting of two stages: Stage 1 was a dose-escalation study to assess the safety and tolerability profile of three escalating doses of VN-B101 (1, 2, and 4 tablets; qd; for 7 days) in healthy subjects, while Stage 2 applied VN-B101 as add-on treatment to MET in T2DM. There was no AEs or SAE found in stage 1 and stage 2 subjects. In addition, the combination treatment significantly reduced OGTT incremental glucose AUC by additional 35% (p<0.05) compared to MET monotherapy.
In summary, VN-B101 as add-on therapy to MET is safe and efficacious in T2DM inadequately controlled by MET alone. The inspiring study results encourage further clinical studies to be conducted.
H. Chen: None. P. Wang: None.
