Diabetes Mellitus, Type 2Phase 3NCT06140485
A Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients With Type II Diabetes Mellitus
A Phase 3 study testing NW Low-Glu® and Metformin in people with Diabetes Mellitus, Type 2, run by Natural Wellness Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- NW Low-Glu® and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Phase III, Randomized, Double-Blind, Double-Dummy, Active- Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients With Type II Diabetes Mellitus
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.
Read the 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. Not only do plants serve as foods, but they have also been an integral part of therapeutic interventions in traditional and alternative medicine throughout human history. Because plants comprise a large number of monomeric compounds, herbal medicine continues to play a multi-targeted approach role in treating diseases.
It is estimated that 25% of modern drugs are derived from natural products. In addition, the World Health Organization (WHO) estimates that between 65% and 80% of developing countries use medicinal plants as remedies. In a study conducted in Alexandria, Egypt, the rate of using complementary and alternative medicine (CAM) at least once among type 2 diabetes mellitus (T2DM) patients was 41.7%, with 26.3% being regular CAM users. The main reason for resorting to CAM was the belief in its benefits. The powdered extracts of Ficus deltoidea leaves, Cinnamomum cassia bark, and Nigella Sativa seeds (Black Seeds) have been used for the treatment of diabetes and other medical conditions for over 2000 years. Studies on the individual effect of each of these medicinal plants have demonstrated antihyperglycemic efficacy in individuals with T2DM. For example, Kalman et al. reported significant reduction in glucose and lipid levels upon testing the antidiabetic effects of F. deltoidea in adults with prediabetes. There is also strong evidence to support the efficacy of Cinnamomum cassia in lowering fasting plasma glucose (FPG). In a randomized controlled trial, poorly controlled T2DM patients receiving an aqueous extract equivalent to 3 grams of Cinnamomum cassia for 4 months had significantly higher reduction in FPG compared to placebo (10.3% vs 3.4%). Furthermore, Nigella Sativa seeds' extract (in combination with oral hypoglycemic drugs) led to significant reductions in FPG, 2-hour post-prandial glucose (2 hr PPG), HbA1c, and insulin resistance at 12 weeks, which makes it a possible beneficial adjuvant therapy to oral hypoglycemics in patients with uncontrolled T2DM. A combination of the mentioned medicinal herbs is registered as NW Low-Glu® (a dietary supplement; one capsule constitutes 300 mg Mas Cotek powdered extract [from leaves of Ficus deltoidea Jack by aqueous solvent extraction] + 100 mg Cinnamomum cassia L. powdered extract +250 mg Black Seed powdered extract [from seeds of Nigella sativa L. by 70% hydro-alcoholic extraction]) in the Malaysian market under the registration number MAL15070037 T.
The efficacy and safety NW Low-Glu® was investigated in a phase II study in 2022, in which the hypoglycemic effect of two doses of the herbal medicinal product was compared in patients newly diagnosed with T2DM. Correspondingly, the results of the phase II study warranted further assessment of NW Low-Glu® activity in patients inclined to benefit from it.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NW Low-Glu®, Metformin
- Keywords
- Type 2 diabetes mellitus, Complementary medicine, Alternative medicine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
MetforminDrug
Patients in the active comparator arm will receive a total of 2000 mg of metformin per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To compare the hypoglycemic effect of a herbal medicinal product (NW Low-Glu) to that of metformin as measured by the mean change in fasting blood glucose levels in patients with type II diabetes mellitus.
Measured: 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
To measure the incidence of adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), hypoglycemic events, and abnormal laboratory test findings in both the experimental arm and active comparator arm
Measured: 6 months
Assessing cardiovascular AEs in both the experimental arm and the active comparator arm
To measure the number, nature, and severity of cardiovascular AEs and their causal relationship to the received intervention in both the experimental arm and active comparator arm
Measured: 6 months
Comparing the mean change in weight between the experimental arm and the active-control arm
To compare the mean change in body weight between the experimental arm and the active comparator arm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study startMar 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Wellness Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140485
- Sponsor's protocol ID
- NW_LowGlu_18052023
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Double-Dummy, Active- Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06140485
- Acronym / sponsor ID
- NW_LowGlu_18052023
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Complementary medicine, Alternative medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Natural Wellness EgyptIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Not only do plants serve as foods, but they have also been an integral part of therapeutic interventions in traditional and alternative medicine throughout human history. Because plants comprise a large number of monomeric compounds, herbal medicine continues to play a multi-targeted approach role in treating diseases.
It is estimated that 25% of modern drugs are derived from natural products. In addition, the World Health Organization (WHO) estimates that between 65% and 80% of developing countries use medicinal plants as remedies. In a study conducted in Alexandria, Egypt, the rate of using complementary and alternative medicine (CAM) at least once among type 2 diabetes mellitus (T2DM) patients was 41.7%, with 26.3% being regular CAM users. The main reason for resorting to CAM was the belief in its benefits. The powdered extracts of Ficus deltoidea leaves, Cinnamomum cassia bark, and Nigella Sativa seeds (Black Seeds) have been used for the treatment of diabetes and other medical conditions for over 2000 years. Studies on the individual effect of each of these medicinal plants have demonstrated antihyperglycemic efficacy in individuals with T2DM. For example, Kalman et al. reported significant reduction in glucose and lipid levels upon testing the antidiabetic effects of F. deltoidea in adults with prediabetes. There is also strong evidence to support the efficacy of Cinnamomum cassia in lowering fasting plasma glucose (FPG). In a randomized controlled trial, poorly controlled T2DM patients receiving an aqueous extract equivalent to 3 grams of Cinnamomum cassia for 4 months had significantly higher reduction in FPG compared to placebo (10.3% vs 3.4%). Furthermore, Nigella Sativa seeds' extract (in combination with oral hypoglycemic drugs) led to significant reductions in FPG, 2-hour post-prandial glucose (2 hr PPG), HbA1c, and insulin resistance at 12 weeks, which makes it a possible beneficial adjuvant therapy to oral hypoglycemics in patients with uncontrolled T2DM. A combination of the mentioned medicinal herbs is registered as NW Low-Glu® (a dietary supplement; one capsule constitutes 300 mg Mas Cotek powdered extract [from leaves of Ficus deltoidea Jack by aqueous solvent extraction] + 100 mg Cinnamomum cassia L. powdered extract +250 mg Black Seed powdered extract [from seeds of Nigella sativa L. by 70% hydro-alcoholic extraction]) in the Malaysian market under the registration number MAL15070037 T.
The efficacy and safety NW Low-Glu® was investigated in a phase II study in 2022, in which the hypoglycemic effect of two doses of the herbal medicinal product was compared in patients newly diagnosed with T2DM. Correspondingly, the results of the phase II study warranted further assessment of NW Low-Glu® activity in patients inclined to benefit from it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NW Low-Glu® | Experimental | Dietary Supplement: NW Low-Glu®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. |
| Metformin | Active comparator | Drug: MetforminPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NW Low-Glu®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). | Dietary supplement | NW Low-Glu® |
| MetforminPatients in the active comparator arm will receive a total of 2000 mg of metformin per day. | Drug | Metformin |
Primary outcome
Comparing the mean change in HbA1c levels between the experimental arm and the active-control arm
Time frame: 6 months
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.
4 secondary outcomes
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
Time frame: 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
Time frame: 6 months
Assessing cardiovascular AEs in both the experimental arm and the active comparator arm
Time frame: 6 months
Comparing the mean change in weight between the experimental arm and the active-control arm
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NW Low-Glu® and Metformin in people with Diabetes Mellitus, Type 2, run by Natural Wellness Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the mean change in HbA1c levels between the experimental arm and the active-control arm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.