Status:
UNKNOWN
A Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients With Type II Diabetes Mellitus
Lead Sponsor:
Natural Wellness Egypt
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 t...
Detailed Description
Despite the advancements in drug discovery and the increase in the total budget spent on pharmaceutical research and development, the number of new drug approvals has decreased in the recent years. No...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06140485
Start Date
March 1 2024
End Date
October 1 2025
Last Update
November 22 2023
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