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

NCT05439473 | Completed Phase 2

• 1 other identifier: Cura-02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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)

• 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%.

  1 month

Secondary Outcomes (3)

• Effect of Curalin on Fructosamin based on blood tests

  1 month

• Efect of Curalin on Fasting Blood Glucose Blood for glucose assessment

  1 month

• Safety of Curalin as assessed by adverse events

  1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Curalin

Treatment

ACTIVE COMPARATOR

Dietary Supplement: Curalin

Interventions

Curalin DIETARY_SUPPLEMENT

Supplement 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:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CuraLife: lead

Study Sites (1)

DMC

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 30, 2022
• Study Start: August 3, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

IL (1)