A Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients With Type II Diabetes Mellitus

NCT06140485 | Unknown Phase 3

• 1 other identifier: NW_LowGlu_18052023
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to investigate efficacy and safety of an herbal medicinal product of (NW Low-Glu®) in patients with Type 2 Diabetes Mellitus (T2DM). The main question\[s\] it aims to answer are: • What will be the mean change in HbA1c levels in the experimental arm (NW Low-Glu®) compared to the active-control arm (metformin) after 6 months of treatment? Participants will randomized in a 1:1 allocation ratio, into one of the two treatment groups, to receive either Metformin or NW Low-Glu®. Researchers will compare the mean change in HbA1C, fasting blood glucose, and weight between the experimental arm and the active-control arm.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; Complementary medicine; Alternative medicine

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (4)

• Comparing the mean change in HbA1c levels between the experimental arm and the active-control arm Comparing the mean change in fasting blood glucose levels

  6 months

• Measuring the incidence of AEs, SAEs, TEAEs, hypoglycemic events, and abnormal laboratory test findings in both the experimental arm and the active comparator arm

  6 months

• Assessing cardiovascular AEs in both the experimental arm and the active comparator arm

  6 months

• Comparing the mean change in weight between the experimental arm and the active-control arm

  6 months

Study Arms (2)

NW Low-Glu®

EXPERIMENTAL

Patients in this arm will receive one placebo tablet plus two NW Low-Glu® capsules administered PO on empty stomach with plenty of water 2 hours after meals twice daily. A total dose of four NW Low-Glu® capsules will be administered per day.

Dietary Supplement: NW Low-Glu®

Metformin

ACTIVE COMPARATOR

Patients in this arm will receive one metformin 1000 mg tablet plus two placebo capsules administered PO on an empty stomach with plenty of water 2 hours after meals twice daily. A total dose of Metformin 2000 mg will be administered per day.

Drug: Metformin

Interventions

NW Low-Glu® DIETARY_SUPPLEMENT

One NW Low-Glu® capsule contains Mas Cotek powdered Extract 300 mg (from leaves of Ficus deltoidea Jack by aqueous solvent extraction) + Cinnamomum cassia L. powdered Extract 100 mg + Black seed powdered extract 250 mg (from seeds of Nigella sativa L. by 70% hydro-alcoholic extraction).

NW Low-Glu®

Metformin DRUG

Patients in the active comparator arm will receive a total of 2000 mg of metformin per day.

Metformin

Eligibility Criteria

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

You may qualify if:

• Patients must meet all of the following criteria to be eligible for enrolment into the study.
• Able and willing to provide written informed consent.
• Male and female patients aged between 18 and 65 years.
• Recently diagnosed patients with T2DM (within two years prior to enrollment).
• Patients with dysglycemia with HbA1c of 5.7%-8.7%.
• Treatment-naïve patients OR patients who discontinued their anti-diabetic medications within three months prior to enrollment.

You may not qualify if:

• Patients meeting any of the following criteria are not eligible for enrolment into the study.
• 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 one month after their last dose of study drug.
• Patients with BMI \> 40 Kg/m2 or BMI \< 18.5 Kg/m2.
• Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (measured by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation).
• History of positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG), or hepatitis C (HCV) 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 five 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.

Sponsors & Collaborators

• Natural Wellness Egypt: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 20, 2023
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share