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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02123732
• Other study ID #: DbXell1234
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 2, 2014
• Last updated: March 5, 2017
• Start date: July 2014

Study information

• Verified date: March 2017
• Source: Laniado Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• DbXell

• Placebo

Locations

Country	Name	City	State
Israel	Laniado Hospital, Diabetes Unit	Netanya

Sponsors (2)

Lead Sponsor	Collaborator
Laniado Hospital	K.G.S Research & Entrepreneurship, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1C concentrations and fasting glucose levels		6 months from last patient in