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

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Natural Wellness Egypt
• Treatments: Metformin

Criteria

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for enrolment into the study.

1. Able and willing to provide written informed consent.

2. Male and female patients aged between 18 and 65 years.

3. Recently diagnosed patients with T2DM (within two years prior to enrollment).

4. Patients with dysglycemia with HbA1c of 5.7%-8.7%.

5. Treatment-naïve patients OR patients who discontinued their anti-diabetic medications within three months prior to enrollment.

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for enrolment into the study.

1. 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.

2. Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.

3. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (measured by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation).

4. History of positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG), or hepatitis C (HCV) antibody test.

5. History of type I diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's syndrome or acromegaly.

6. 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).

7. History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data.

8. History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding.

9. History of an eating disorder (e.g., bulimia, anorexia).

10. History of malignancy (except treated basal or squamous cell skin cancer) within five years prior to screening.

11. History of significant cardiovascular disease (such as congestive heart failure, myocardial infarction, coronary disease) or uncontrolled hypertension.

12. History of clinically significant renal or liver disease.

13. Receipt of an investigational drug within 30 days prior to screening, or active enrollment in another investigational medication or device trial.

14. Known or suspected allergy to the trial products.

15. 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.