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

November 20, 2022 updated by: CuraLife

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

Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults with Type 2 Diabetes Mellitus

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Be'er Sheva, Israel
        • Recruiting
        • Soroka Medical Center
        • Contact:
        • Principal Investigator:
          • Idit Liberty, MD
      • Haifa, Israel
        • Recruiting
        • Lin Medical Center
        • Contact:
        • Principal Investigator:
          • Michal Gershinsky, MD
      • Herzliya, Israel
        • Recruiting
        • Herzelia Diebetes Center
        • Contact:
        • Principal Investigator:
          • Eitan Roitman, MD
      • Tel Aviv, Israel
        • Recruiting
        • Ichilov Medical Center
        • Contact:
        • Principal Investigator:
          • Roy Eldor, MD

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Diagnosis and Criteria for Inclusion:

Patients may be included in the study if they meet all of the following criteria:

  • Written informed consent is obtained.
  • Adult patients (18-85 years of age) with Type II diabetes mellitus
  • HbA1c at screening is 7.5% - 10%
  • 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.

Criteria for Exclusion: Patients will be excluded from participating in this study if they meet 1 or more of the following criteria:

  • Patients who have been using Curalin At least once in the past 3 months
  • 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 childbearing 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

  • The 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 under 130 mEq/L
  • Hemoglobin under 10 g/dl for Women or Under 11 g/dl for man

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Curalin
Curalin capsules, 2 capsules, 3 times a day after meals Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals
Active Comparator: Treatment
Dietary supplement: Curalin
Curalin capsules, 2 capsules, 3 times a day after meals Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary objective
Time Frame: 3-6 months
The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c.
3-6 months

Collaborators and Investigators

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

Sponsor

CuraLife

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)

October 15, 2021

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

November 20, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 20, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cura-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Type2 Diabetes

Clinical Trials on Curalin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe