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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02123732

Enrollment

Registered

2014-04-28

Start date

2014-07-31

Completion date

Unknown

Last updated

2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes, Diabetes Mellitus, Herbal, food supplement

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.

Interventions

DIETARY_SUPPLEMENTDbXell

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Change in HbA1C concentrations and fasting glucose levels	6 months from last patient in

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026