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Evaluation of the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Curalin
Sponsored by
CuraLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring Diabetes, Type 2 Diabetes, placebo, Curalin, CuraLife, Momordica Charantia, Gymnema Sylvestre, Trigonella Foenum Graecum, Curcuma Longa, Emblica Officinalis, Swertia Chirata, Picrorhiza Kurroa, Syzygium Cumini/ Eugenia Jambolana, Cinnamomum Zeylanicum

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent is obtained.
  • Adult patients (18-85 years of age) with Type II diabetes mellitus.
  • HbA1c at screening is 8% - 11%.
  • Body mass index (BMI)>25.
  • Stable body weight (±10%) within the 3 months preceding study entry.
  • Patients were steadily treated with anti-diabetic medications, such as: GLP-1, Glucophage DPP-4 inhibitor or SGLT-2 inhibitor for at least 3 months or more prior to study entry.
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow up evaluation as specified in this protocol.

Exclusion Criteria:

  • Patients who have been using Curalin
  • Persons with known sensitivity to any of the components of the Curalin product.
  • The patient has any clinically significant uncontrolled medical condition (treated or untreated).
  • Patients with renal insufficiency (glomerular filtration rate [GFR]≤30 mL/min/1.73m2).
  • Pregnant or lactating women. Women of child bearing potential will be administered a urine pregnancy test at study entry. All study participants will confirm their willingness to use birth control throughout the study.
  • Patients deemed by the Investigator as unable to complete study participation.
  • Patients currently treated with insulin or those that have been treated with insulin for more than 10 days in the 3 months prior to study entry.
  • Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, local, dermal and inhaled steroids, and immunosuppressive or immunomodulating agents for more than a month prior to study entry, or during the study.
  • Patient participated in a clinical study (investigational study drug or study device) within 30 days of the study entry.
  • Life expectancy less than 1 year.
  • History of stroke, transient ischemic attack, or myocardial infarction within six months prior to screening.
  • Patients with uncontrolled hypertension defined as a systolic blood pressure ≥180 mmHg or a diastolic blood pressure ≥100mmHg.
  • Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal.
  • Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal.
  • Patients with creatine kinase concentrations > 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1).
  • Laboratory abnormalities at screening including:
  • Potassium > 5.5 mEq/L
  • Sodium ≤ 130 mEq/L
  • Hemoglobin under 10 g/dl for Women or Under 11 g/dl for man.

Sites / Locations

  • DMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Effect of treatment with Curalin on the change in plasma HbA1c
The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c. Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The primary endpoint of the study is HbA1c at 1 month. Blood for HbA1c will be taken at Screening, and M1/Termination of Study. HbA1c level will be ascertained at the local lab, according to the lab's operating procedures Rate of patients that significantly improved their HbA1c levels at least 0.5%.

Secondary Outcome Measures

Effect of Curalin on Fructosamin based on blood tests
To evaluate the effect of Curalin on Fructosamin level based on blood tests(mmol/L)
Efect of Curalin on Fasting Blood Glucose Blood for glucose assessment
To evaluate the effect of Curalin on Fasting Blood Glucose Blood for glucose assessment will be taken after a 12 hour fast at Screening, Baseline, and M1/Termination of PC Study. Fasting blood glucose level will be ascertained at the local site lab, according to the site's operating procedures. In addition, participants will self-monitor their blood glucose levels at home once a week using a blood glucose meter.
Safety of Curalin as assessed by adverse events
To evaluate the safety of Curalin as assessed by adverse events, including the following: Fasting blood chemistry including (in addition to the efficacy variables of Fructosamine): HbA1c, glucose, urea, creatinine, phosphorus, calcium, potassium, albumin, sodium (Na+) and liver function tests (ALT, AST, bilirubin and GGT), GFR, CBC. Vital Signs including (in addition to the efficacy variable of blood pressure): pulse rate, body temperature

Full Information

First Posted
June 8, 2021
Last Updated
June 25, 2022
Sponsor
CuraLife
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1. Study Identification

Unique Protocol Identification Number
NCT05439473
Brief Title
Evaluation of the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus
Official Title
A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CuraLife

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus
Detailed Description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
Diabetes, Type 2 Diabetes, placebo, Curalin, CuraLife, Momordica Charantia, Gymnema Sylvestre, Trigonella Foenum Graecum, Curcuma Longa, Emblica Officinalis, Swertia Chirata, Picrorhiza Kurroa, Syzygium Cumini/ Eugenia Jambolana, Cinnamomum Zeylanicum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Treatment
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Curalin
Intervention Description
Supplement capsules, 2 capsules, 3 times a day after meals. Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals.
Primary Outcome Measure Information:
Title
Effect of treatment with Curalin on the change in plasma HbA1c
Description
The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c. Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The primary endpoint of the study is HbA1c at 1 month. Blood for HbA1c will be taken at Screening, and M1/Termination of Study. HbA1c level will be ascertained at the local lab, according to the lab's operating procedures Rate of patients that significantly improved their HbA1c levels at least 0.5%.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Effect of Curalin on Fructosamin based on blood tests
Description
To evaluate the effect of Curalin on Fructosamin level based on blood tests(mmol/L)
Time Frame
1 month
Title
Efect of Curalin on Fasting Blood Glucose Blood for glucose assessment
Description
To evaluate the effect of Curalin on Fasting Blood Glucose Blood for glucose assessment will be taken after a 12 hour fast at Screening, Baseline, and M1/Termination of PC Study. Fasting blood glucose level will be ascertained at the local site lab, according to the site's operating procedures. In addition, participants will self-monitor their blood glucose levels at home once a week using a blood glucose meter.
Time Frame
1 month
Title
Safety of Curalin as assessed by adverse events
Description
To evaluate the safety of Curalin as assessed by adverse events, including the following: Fasting blood chemistry including (in addition to the efficacy variables of Fructosamine): HbA1c, glucose, urea, creatinine, phosphorus, calcium, potassium, albumin, sodium (Na+) and liver function tests (ALT, AST, bilirubin and GGT), GFR, CBC. Vital Signs including (in addition to the efficacy variable of blood pressure): pulse rate, body temperature
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent is obtained. Adult patients (18-85 years of age) with Type II diabetes mellitus. HbA1c at screening is 8% - 11%. Body mass index (BMI)>25. Stable body weight (±10%) within the 3 months preceding study entry. Patients were steadily treated with anti-diabetic medications, such as: GLP-1, Glucophage DPP-4 inhibitor or SGLT-2 inhibitor for at least 3 months or more prior to study entry. The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow up evaluation as specified in this protocol. Exclusion Criteria: Patients who have been using Curalin Persons with known sensitivity to any of the components of the Curalin product. The patient has any clinically significant uncontrolled medical condition (treated or untreated). Patients with renal insufficiency (glomerular filtration rate [GFR]≤30 mL/min/1.73m2). Pregnant or lactating women. Women of child bearing potential will be administered a urine pregnancy test at study entry. All study participants will confirm their willingness to use birth control throughout the study. Patients deemed by the Investigator as unable to complete study participation. Patients currently treated with insulin or those that have been treated with insulin for more than 10 days in the 3 months prior to study entry. Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, local, dermal and inhaled steroids, and immunosuppressive or immunomodulating agents for more than a month prior to study entry, or during the study. Patient participated in a clinical study (investigational study drug or study device) within 30 days of the study entry. Life expectancy less than 1 year. History of stroke, transient ischemic attack, or myocardial infarction within six months prior to screening. Patients with uncontrolled hypertension defined as a systolic blood pressure ≥180 mmHg or a diastolic blood pressure ≥100mmHg. Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal. Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal. Patients with creatine kinase concentrations > 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1). Laboratory abnormalities at screening including: Potassium > 5.5 mEq/L Sodium ≤ 130 mEq/L Hemoglobin under 10 g/dl for Women or Under 11 g/dl for man.
Facility Information:
Facility Name
DMC
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

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Evaluation of the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus

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