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

Abstract

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® (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L. + 250 mg Nigella sativa L. powdered extracts) in treatment-naïve, 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® (content of four capsules per day), or high-dose NW Low-Glu® (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® 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.