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

Laniado Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: DbXell; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02123732

DbXell1234

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

DbXell

Experimental group

Description:

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.

Treatment:

Dietary Supplement: DbXell

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo