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

NCT ID: NCT02123732

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

DbXell

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

DbXell

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KGS Research

OTHER

Sponsor Role: collaborator

Laniado Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laniado Hospital

Dr Mark J NIVEN Director of Endocrine and Diabetes Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark J Niven, MD

Role: PRINCIPAL_INVESTIGATOR

Laniado Hospital

Locations

Laniado Hospital, Diabetes Unit

Netanya, , Israel

Countries

Israel

Other Identifiers

DbXell1234

Identifier Type: -

Identifier Source: org_study_id