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

April 27, 2022 updated by: Natural Wellness Egypt

A Phase II, Randomized, Double Blind, Double Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes Mellitus (DM), commonly referred to as Diabetes is defined by World Health Organization (WHO) as a group of metabolic disorders characterized by chronic Hyperglycemia resulting from defects in insulin secretion, insulin action or both. Long-term organ damage, organ dysfunction and organ failure are associated with the chronic Hyperglycemia of Diabetes. Possible Diabetes complications can be classified into two major categories; macrovascular and microvascular including Ischemic Heart Disease (IHD), Peripheral Vascular Disease (PVD), and Cerebrovascular Disease (CVD) "macrovascular", and Nephropathy, Retinopathy, and Neuropathy "microvascular" resulting in organ and tissue damage in almost one third to one half of population with diabetes.

According to the International Diabetes Federation (IDF), the three main types of Diabetes are Type 1 Diabetes, Type 2 Diabetes and Gestational Diabetes. Type 1 DM, formerly described as "Insulin Dependent Diabetes Mellitus" (IDDM) results from β-cells destruction, usually leading to absolute deficiency of insulin. Type 2 DM formerly described as "Non-Insulin-Dependent Diabetes Mellitus" (NIDDM) results from a progressive insulin secretory defect on the background of insulin resistance. Gestational Diabetes, which appears during pregnancy, is associated with increasing the risk of developing type 2 Diabetes in both mother and child later in life.

Diabetes is a rapidly growing health concern in both developed and developing nations and its prevalence is continuously increasing worldwide. Globally, in 2014, approximately 422 million adults were having diabetes, with type 2 making up about 91%of the cases. In 2015, according to IDF, an estimated 415 million adults were having diabetes along with an estimated 318 million adults with impaired glucose tolerance. Both WHO and IDF predict that by 2030, this number will be doubled. In 2016 the WHO global report on Diabetes stated that the prevalence of Diabetes has increased faster in low- and middle-income countries than in high-income countries.

Type 2 Diabetes is characterized by insulin resistance and/or abnormal insulin secretion, either of which may predominate. It is associated with several metabolic defects such as obesity, hypertension, and dyslipidemia, which contribute to the very high rate of cardiovascular morbidity and mortality.

Medicinal herbs were used to treat a wide range of diseases long time before the birth of conventional medicine systems. The World Health Organization (WHO) has listed 21,000 plant names, which are used for medicinal purposes around the world, so despite the fact that medicinal herbs are at times misconceived as being unscientific, their continual existence proves they are able to be alternatives or complementary to conventional drugs at some point.

Specifically, Ficus deltoidea leaves, Cinnamomum cassia L. powdered Extract and Black seed powdered extract have been used for the treatment of Diabetes Mellitus and other medical conditions for over 2000 years. Ficus deltoidea is an evergreen shrub reaching to 2 meters of height, with whitish grey bark, broadly spoon-shaped to obovate leaves and spherical or round figs. Over the years, it has been used to treat many diseases such as; Diabetes Mellitus, Hypertension, Hyperlipidemia and Gout. Numerous studies were conducted over the past years to assess the safety of Ficus deltoidea, Cinnamomum cassia L. powdered extract and Black seed powdered extract and their efficacy in treating type 2 Diabetes Mellitus.

As the available data on NW Low-Glu efficacy, safety and dosing regimen is not enough, this study will be conducted to compare the hypoglycemic effect of two doses of a herbal medicinal product of ficus and Cinnamomum cassia L. powdered Extract + Black seed powdered extract (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.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 11765
        • Natural Welness Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Able and willing to provide written informed consent.
  2. Males and females aged between 18 and 65 years of age.
  3. 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%
  4. Anti-diabetic treatment naïve patients.
  5. Able and willing to perform SMBG and to complete subject diaries.

Exclusion Criteria:

  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 1 month after their last dose of study drug.
  2. Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.
  3. eGFR <60 mL/min/1.73 m2 (measured by the CKD-EPI equation) 3.
  4. History of Positive human immunodeficiency virus, hepatitis B surface antigen (HBsAG), or hepatitis C 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 5 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm 1 Metformin ( 64 patients)

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
A total dose of 2000 mg was administered per day.
Experimental: Experimental Arm 2: Low Dose NW Low-Glu ( 65 patients)

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
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
Other Names:
  • Mas Cotek powdered Extract 300 mg + Cinnamomum cassia L. powdered Extract 100 mg + Black seed powdered extract 250 mg
Experimental: Experimental Arm 3: High Dose NW Low-Glu ( 69 patients)

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 weeks
Comparing the mean change in HbA1c levels between each experimental arm and active-control arm
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the incidence of hypoglycemia events and other adverse events in patients newly diagnosed with type II diabetes mellitus (Safety)
Time Frame: 12 weeks
Comparing the mean change in fasting plasma glucose levels between each experimental arm and active-control arm
12 weeks
To compare the mean change in the 2h-post prandial glucose levels between each experimental arm and active-control arm (efficacy)
Time Frame: 12 weeks
To compare the mean change in the 2h-post prandial glucose levels between each experimental arm and active-control arm.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcome
Time Frame: 12 weeks
To explore the effect of NW Low-Glu on Beta cell function in patients newly diagnosed with type II diabetes mellitus by assessing through HOMA-β modeling.
12 weeks
Measuring the activity of alpha-glucosidase enzyme to investigate the effect of NW Low-Glu on intestinal glucose absorption
Time Frame: 12 weeks
To investigate the effect of NW Low-Glu on intestinal glucose absorption by measuring the activity of alpha-glucosidase enzyme.
12 weeks
To investigate the effect of NW Low-Glu on weight.
Time Frame: 12 weeks
To investigate the effect of NW Low-Glu on weight by comparing patients' weight before and after the intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Wellness Egypt

Investigators

  • Principal Investigator: Prof. Dr Samir Helmy Assaad, MD, University of Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2018

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

April 10, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NW_Low-Glu_14122016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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