Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus

NCT02123732 | Unknown Phase 1

• 1 other identifier: DbXell1234
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but less than 8.0% on their current conventional therapy.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Diabetes Mellitus; Herbal; food supplement

Outcome Measures

Primary Outcomes (1)

• Change in HbA1C concentrations and fasting glucose levels

  6 months from last patient in

Study Arms (2)

DbXell

EXPERIMENTAL

Drug: DbXell three times daily for 12 weeks and then switching to Placebo of DbXell for 12 additional months Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Dietary Supplement: DbXell

Placebo

PLACEBO COMPARATOR

Drug: Placebo of DbXell Placebo of DbXell three times daily for 12 weeks and then switching to DbXell for 12 additional weeks Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Dietary Supplement: Placebo

Interventions

DbXell DIETARY_SUPPLEMENT

DbXell

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects with age of 18-70 years Established type 2 diabetes mellitus as defined by the American Diabetes Association, but of duration less than 10 years.
• Suboptimal glycemic control as judged by HbA1c over target but not more than 8.0%.Current medication of not more than 2 oral hypoglycemic agents. No current or past insulin or GLP1 therapy.
• FPG ≤ 180 mg/dL
• Hemoglobin level of ≥ 10.0 g/dL
• Serum ALT ≤ 2.5 times upper limit of normal
• Serum creatinine \< 1.5 times upper limit of normal

You may not qualify if:

• Female of childbearing potential
• Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
• Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg)
• History of renal and/or liver disease
• History of or the presence of any clinical evidence of malignancies
• Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
• Current treatment with systemic corticosteroids or herbal (alternative) medicines
• Participation in any other intervention trial within 30 days prior to Screening

Sponsors & Collaborators

• Laniado Hospital: lead
• KGS Research: collaborator

Study Sites (1)

Laniado Hospital, Diabetes Unit

Netanya, 42150, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark J Niven, MD

  Laniado Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mark J NIVEN Director of Endocrine and Diabetes Unit

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 28, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2017
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

IL (1)