A Phase II, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients Newly Diagnosed with Type 2 Diabetes Mellitus

cited. Background. Medicinal plants have long been used for the treatment of type 2 diabetes mellitus (T2DM). This study aimed to investigate the hypoglycemic efficacy and safety of NW Low-Glu (R) (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L. + 250 mg Nigella sativa L. powdered extracts) in treatment-naive, newly diagnosed T2DM patients. Methods. This was a 12-week, double-blind, double-dummy, randomized, phase 2 clinical trial. A total of 232 male and female patients aged >= 18 and <= 65 years who were newly diagnosed with T2DM and have not received any antidiabetic drugs before and were equally randomized to receive metformin (2000 mg per day), low-dose NW Low-Glu (R) (content of four capsules per day), or high-dose NW Low-Glu (R) (content of five capsules per day). Our primary objective was to measure the mean change in HbA1c between each of the experimental arms and the metformin arm. Results. There was a significant reduction in mean HbA1c at 12 weeks compared to baseline in the low-dose (0.6 (1.4)%; p = 0.002) and high-dose arms (0.8 (1.7)%; p = 0.004). There was also a significant reduction in 2 hr PPG at 12 weeks in the low-dose (35.4 (74.9) mg/dL, p = 0.001) and high-dose arms (24.7 (100.8) mg/dL, p = 0.04). Weight reduction was significantly higher with both high-dose (1.1 (-1.7) Kg; p = 0.005) and low-dose arms (0.9 (-1.5) Kg; p = 0.023) compared to metformin (0.8 (-1.8) Kg). No serious AEs or deaths were reported. Conclusions. After 3 months of treatment, NW Low-Glu (R) was noninferior to metformin in reducing HbA1c and 2 hr PPG, while leading to significantly higher weight reduction in newly diagnosed T2DM patients. It was also safe and well tolerated.