Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus

NCT05343767 | Completed DMC

• 1 other identifier: NW_Low-Glu_14122016
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Ficus deltoidea leaves, Cinnamomum cassia and Black seed powdered extract have long been used for the treatment of type 2 diabetes mellitus.

Conditions

Type2 Diabetes Mellitus

Keywords

Ficus deltoidea; HbA1c; weight; metabolic syndrome; medicinal plants

Outcome Measures

Primary Outcomes (1)

• To compare the hypoglycemic effect of two doses of a herbal medicinal product (NW Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients newly diagnosed with type II diabetes mellitus.

  Comparing the mean change in HbA1c levels between each experimental arm and active-control arm

  12 weeks

Secondary Outcomes (2)

• To measure the incidence of hypoglycemia events and other adverse events in patients newly diagnosed with type II diabetes mellitus (Safety)

  12 weeks

• To compare the mean change in the 2h-post prandial glucose levels between each experimental arm and active-control arm (efficacy)

  12 weeks

Other Outcomes (3)

• Exploratory outcome

  12 weeks

• Measuring the activity of alpha-glucosidase enzyme to investigate the effect of NW Low-Glu on intestinal glucose absorption

  12 weeks

• To investigate the effect of NW Low-Glu on weight.

  12 weeks

Study Arms (3)

Control Arm 1 Metformin ( 64 patients)

ACTIVE COMPARATOR

Metformin 1000 mg tablets were used. * First Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Second Dose: Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Third Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals. A total dose of 2000 mg was administered per day.

Other: Metformin

Experimental Arm 2: Low Dose NW Low-Glu ( 65 patients)

EXPERIMENTAL

The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows: * First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.

Dietary Supplement: Natural Wellness Low-Glu low dose

Experimental Arm 3: High Dose NW Low-Glu ( 69 patients)

EXPERIMENTAL

The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows: * First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.

Dietary Supplement: Natural Wellness Low-Glu high dose

Interventions

Natural Wellness Low-Glu low dose DIETARY_SUPPLEMENT

The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses

Also known as: Mas Cotek powdered Extract 300 mg + Cinnamomum cassia L. powdered Extract 100 mg + Black seed powdered extract 250 mg

Experimental Arm 2: Low Dose NW Low-Glu ( 65 patients)

Natural Wellness Low-Glu high dose DIETARY_SUPPLEMENT

The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses

Experimental Arm 3: High Dose NW Low-Glu ( 69 patients)

Metformin OTHER

A total dose of 2000 mg was administered per day.

Control Arm 1 Metformin ( 64 patients)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent.
• Males and females aged between 18 and 65 years of age.
• Newly diagnosed with type II diabetes mellitus patients as per the following criteria (FBG ≥ 126 mg/dl) or, 2h- post prandial ≥ 200 mg/dl during OGTT or, HbA1c ≥ 6.5%
• Anti-diabetic treatment naïve patients.
• Able and willing to perform SMBG and to complete subject diaries.

You may not qualify if:

• Pregnant or lactating women; women of childbearing potential must agree to use an accepted method of contraception during the course of the study and for 1 month after their last dose of study drug.
• Patients with BMI \> 40 Kg/m2 or BMI \< 18.5 Kg/m2.
• eGFR \<60 mL/min/1.73 m2 (measured by the CKD-EPI equation) 3.
• History of Positive human immunodeficiency virus, hepatitis B surface antigen (HBsAG), or hepatitis C antibody test.
• History of type I diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's syndrome or acromegaly.
• History of diabetic complications such as diabetic ketoacidosis, lactic acidosis or state of hyperosmolar hyperglycemia, diabetic proliferative retinopathy, or severe diabetic neuropathy (requiring treatment with antidepressants or opioids) and history of decompensated diabetes (polyuria, polydipsia, nocturia, fatigue).
• History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data.
• History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding.
• History of an eating disorder (e.g., bulimia, anorexia).
• History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to screening.
• History of significant cardiovascular disease (such as congestive heart failure, myocardial infarction, coronary disease) or uncontrolled hypertension.
• History of clinically significant renal or liver disease.
• Receipt of an investigational drug within 30 days prior to screening, or active enrollment in another investigational medication or device trial.
• Known or suspected allergy to the trial products.
• Any condition, in the judgment of the investigator, that would interfere with the patient's ability to comply with all study requirements or that would place the patient at unacceptable risk by his/her participation in the study.

Sponsors & Collaborators

• Natural Wellness Egypt: lead

Study Sites (1)

Natural Welness Egypt

Cairo, Nasr City, 11765, Egypt

Location

Related Publications (27)

• Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008 Nov;88(11):1322-35. doi: 10.2522/ptj.20080008. Epub 2008 Sep 18.

  PMID: 18801863 BACKGROUND

• Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

  PMID: 9686693 BACKGROUND

• IDF. IDF Diabetes Atlas · Seventh Edition. 2015.

  BACKGROUND

• WHO. Global report on diabetes. 2016.

  BACKGROUND

• Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

  PMID: 19896746 BACKGROUND

• Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.

  PMID: 11742409 BACKGROUND

• Edelman SV. Type II diabetes mellitus. Adv Intern Med. 1998;43:449-500.

  PMID: 9506190 BACKGROUND

• Pan SY, Pan S, Yu ZL, Ma DL, Chen SB, Fong WF, Han YF, Ko KM. New perspectives on innovative drug discovery: an overview. J Pharm Pharm Sci. 2010;13(3):450-71. doi: 10.18433/j39w2g.

  PMID: 21092716 BACKGROUND

• Bamosa A, Kaatabi H, Badar A, Al-Khadra A, Al Elq A, Abou-Hozaifa B, Lebda F, Al-Almaie S. Nigella sativa: A potential natural protective agent against cardiac dysfunction in patients with type 2 diabetes mellitus. J Family Community Med. 2015 May-Aug;22(2):88-95. doi: 10.4103/2230-8229.155380.

  PMID: 25983604 BACKGROUND

• Jia Q, Liu X, Wu X, Wang R, Hu X, Li Y, Huang C. Hypoglycemic activity of a polyphenolic oligomer-rich extract of Cinnamomum parthenoxylon bark in normal and streptozotocin-induced diabetic rats. Phytomedicine. 2009 Aug;16(8):744-50. doi: 10.1016/j.phymed.2008.12.012. Epub 2009 May 22.

  PMID: 19464860 BACKGROUND

• Corner E. The complex of Fixcus Deltoidea ; A recent invasion of the sunda shelf. Philos Trans R Soc London B, Biol Sci. 1969 Nov;256(808):281-317.

  BACKGROUND

• Hakiman M, Maziah M. Non enzymatic and enzymatic antioxidant activities in aqueous extract of different Ficus deltoidea accessions. J Med Plants Res. 2009;3(3):120-31.

  BACKGROUND

• Sulaiman MR, Hussain MK, Zakaria ZA, Somchit MN, Moin S, Mohamad AS, Israf DA. Evaluation of the antinociceptive activity of Ficus deltoidea aqueous extract. Fitoterapia. 2008 Dec;79(7-8):557-61. doi: 10.1016/j.fitote.2008.06.005. Epub 2008 Jul 10.

  PMID: 18672036 BACKGROUND

• Prakash B, Singh P, Yadav S, Singh SC, Dubey NK. Safety profile assessment and efficacy of chemically characterized Cinnamomum glaucescens essential oil against storage fungi, insect, aflatoxin secretion and as antioxidant. Food Chem Toxicol. 2013 Mar;53:160-7. doi: 10.1016/j.fct.2012.11.044. Epub 2012 Dec 5.

  PMID: 23220615 BACKGROUND

• Tauseef Sultan M, Butt MS, Anjum FM. Safety assessment of black cumin fixed and essential oil in normal Sprague Dawley rats: Serological and hematological indices. Food Chem Toxicol. 2009 Nov;47(11):2768-75. doi: 10.1016/j.fct.2009.08.011. Epub 2009 Aug 21.

  PMID: 19699773 BACKGROUND

• Draman S, Aris M, Razman, SFU A, H A, AR NA, et al. Mas Cotek (Ficus deltoidea): A Possible Supplement for Type II Diabetes: (A Pilot Study). Pertanika J Trop Agric Sci. 2012;35(1):93-102.

  BACKGROUND

• Monnier L, Colette C. Target for glycemic control: concentrating on glucose. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S199-204. doi: 10.2337/dc09-S310. No abstract available.

  PMID: 19875552 BACKGROUND

• American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S111-S124. doi: 10.2337/dc21-S009.

  PMID: 33298420 BACKGROUND

• Handelsman Y, Bloomgarden ZT, Grunberger G, Umpierrez G, Zimmerman RS, Bailey TS, Blonde L, Bray GA, Cohen AJ, Dagogo-Jack S, Davidson JA, Einhorn D, Ganda OP, Garber AJ, Garvey WT, Henry RR, Hirsch IB, Horton ES, Hurley DL, Jellinger PS, Jovanovic L, Lebovitz HE, LeRoith D, Levy P, McGill JB, Mechanick JI, Mestman JH, Moghissi ES, Orzeck EA, Pessah-Pollack R, Rosenblit PD, Vinik AI, Wyne K, Zangeneh F. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY--CLINICAL PRACTICE GUIDELINES FOR DEVELOPING A DIABETES MELLITUS COMPREHENSIVE CARE PLAN--2015--EXECUTIVE SUMMARY. Endocr Pract. 2015 Apr;21(4):413-37. No abstract available.

  PMID: 27408942 BACKGROUND

• Bunawan H, Amin NM, Bunawan SN, Baharum SN, Mohd Noor N. Ficus deltoidea Jack: A Review on Its Phytochemical and Pharmacological Importance. Evid Based Complement Alternat Med. 2014;2014:902734. doi: 10.1155/2014/902734. Epub 2014 Mar 18.

  PMID: 24772185 BACKGROUND

• Choo CY, Sulong NY, Man F, Wong TW. Vitexin and isovitexin from the Leaves of Ficus deltoidea with in-vivo alpha-glucosidase inhibition. J Ethnopharmacol. 2012 Aug 1;142(3):776-81. doi: 10.1016/j.jep.2012.05.062. Epub 2012 Jun 7.

  PMID: 22683902 BACKGROUND

• Adam Z, Khamis S, Ismail A, Hamid M. Ficus deltoidea: A Potential Alternative Medicine for Diabetes Mellitus. Evid Based Complement Alternat Med. 2012;2012:632763. doi: 10.1155/2012/632763. Epub 2012 Jun 3.

  PMID: 22701507 BACKGROUND

• Dugoua JJ, Seely D, Perri D, Cooley K, Forelli T, Mills E, Koren G. From type 2 diabetes to antioxidant activity: a systematic review of the safety and efficacy of common and cassia cinnamon bark. Can J Physiol Pharmacol. 2007 Sep;85(9):837-47. doi: 10.1139/Y07-080.

  PMID: 18066129 BACKGROUND

• Crawford P. Effectiveness of cinnamon for lowering hemoglobin A1C in patients with type 2 diabetes: a randomized, controlled trial. J Am Board Fam Med. 2009 Sep-Oct;22(5):507-12. doi: 10.3122/jabfm.2009.05.080093.

  PMID: 19734396 BACKGROUND

• Akilen R, Tsiami A, Devendra D, Robinson N. Cinnamon in glycaemic control: Systematic review and meta analysis. Clin Nutr. 2012 Oct;31(5):609-15. doi: 10.1016/j.clnu.2012.04.003. Epub 2012 May 12.

  PMID: 22579946 BACKGROUND

• Askari G, Rouhani MH, Ghaedi E, Ghavami A, Nouri M, Mohammadi H. Effect of Nigella sativa (black seed) supplementation on glycemic control: A systematic review and meta-analysis of clinical trials. Phytother Res. 2019 May;33(5):1341-1352. doi: 10.1002/ptr.6337. Epub 2019 Mar 14.

  PMID: 30873688 BACKGROUND

• Daryabeygi-Khotbehsara R, Golzarand M, Ghaffari MP, Djafarian K. Nigella sativa improves glucose homeostasis and serum lipids in type 2 diabetes: A systematic review and meta-analysis. Complement Ther Med. 2017 Dec;35:6-13. doi: 10.1016/j.ctim.2017.08.016. Epub 2017 Aug 30.

  PMID: 29154069 BACKGROUND

MeSH Terms

Conditions

Body Weight; Metabolic Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Prof. Dr Samir Helmy Assaad, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization was done using interactive response technology (IWRS).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a double-blind, double dummy, randomized, active-controlled, three-arm, parallel-group, interventional phase II clinical trial to investigate efficacy and safety of a herbal medicinal product of (NW Low-Glu) in patients newly diagnosed with type II diabetes mellitus. Study duration: 3 months of recruitment and 3 months of treatment. Sample Size: It was planned to enroll 68 patients per arm, 204 in total. Participants were patients between 18 and 65 years of age, newly diagnosed with type II diabetes mellitus and consenting to participate in this study. Eligible patients were randomized in a 1:1:1 allocation ratio, into one of the three treatment groups, to receive either Metformin or one of the two doses of NW Low-Glu.

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 25, 2022
• Study Start: September 12, 2018
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)