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Status unknownNCT02123732Updated Mar 7, 2017

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

A Phase 1/2 interventional study of DbXell and Placebo in Type 2 Diabetes Mellitus, sponsored by Laniado Hospital. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-07.

Sponsored by Laniado Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Diabetes
  • Diabetes Mellitus
  • Herbal
  • food supplement
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Laniado Hospital is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    DbXell

    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 comparator
    Placebo

    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

  • Dietary supplementDbXell
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. Change in HbA1C concentrations and fasting glucose levels

    Time frame: 6 months from last patient in

07

Study locations

1 site
  • Laniado Hospital, Diabetes Unit
    Netanya, 42150, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02123732
Lead sponsor
Laniado Hospital
Collaborators
KGS Research
Responsible party
Laniado Hospital (Dr Mark J NIVEN Director of Endocrine and Diabetes Unit, Laniado Hospital) — Principal investigator
First posted
Apr 28, 2014
Start date
Jul 2014
Primary completion
Feb 2017
Last update
Mar 7, 2017

Study contacts

Mark J Niven, MD
principal investigator · Laniado Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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