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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
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 e...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9532066/ https://www.ncbi.nlm.nih.gov/pubmed/36204125 http://dx.doi.org/10.1155/2022/9176026 |
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author | Assaad-Khalil, Samir Elkafrawy, Nabil Khaled, Mohsen Mogeib, Omneya Badr, Hytham Rashwan, Ahmed Youssef, Mahmoud Eltamawy, Khaled Mohamed, Shahnaz |
author_facet | Assaad-Khalil, Samir Elkafrawy, Nabil Khaled, Mohsen Mogeib, Omneya Badr, Hytham Rashwan, Ahmed Youssef, Mahmoud Eltamawy, Khaled Mohamed, Shahnaz |
author_sort | Assaad-Khalil, Samir |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9532066 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-95320662022-10-05 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 Assaad-Khalil, Samir Elkafrawy, Nabil Khaled, Mohsen Mogeib, Omneya Badr, Hytham Rashwan, Ahmed Youssef, Mahmoud Eltamawy, Khaled Mohamed, Shahnaz Evid Based Complement Alternat Med Research Article 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. Hindawi 2022-09-27 /pmc/articles/PMC9532066/ /pubmed/36204125 http://dx.doi.org/10.1155/2022/9176026 Text en Copyright © 2022 Samir Assaad-Khalil et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Assaad-Khalil, Samir Elkafrawy, Nabil Khaled, Mohsen Mogeib, Omneya Badr, Hytham Rashwan, Ahmed Youssef, Mahmoud Eltamawy, Khaled Mohamed, Shahnaz 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9532066/ https://www.ncbi.nlm.nih.gov/pubmed/36204125 http://dx.doi.org/10.1155/2022/9176026 |
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