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

NCT05631431 | Unknown Phase 2 FDA Drug

• 1 other identifier: Cura-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• primary objective

  The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c.

  3-6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Curalin

Treatment

ACTIVE COMPARATOR

Dietary Supplement: Curalin

Interventions

Curalin DIETARY_SUPPLEMENT

Curalin capsules, 2 capsules, 3 times a day after meals Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• CuraLife: lead

Study Sites (4)

Soroka Medical Center

Beersheba, Israel

RECRUITING

Lin Medical Center

Haifa, Israel

RECRUITING

Herzelia Diebetes Center

Herzliya, Israel

RECRUITING

Ichilov Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ofer Yigdal, Msc/ CPO

CONTACT

+972522582179; Ofer@curalife.com

Liron Hason, Bsc/ CRA

CONTACT

+972543838100; Liron@curalife.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind for 3 months, after 3 months - open-label

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: November 30, 2022
• Study Start: October 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: June 30, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

IL (4)