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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: DbXell
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DbXell<br>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<br> <br> |
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C concentrations and fasting glucose levels |  | 6 months from last patient in | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Diabetes Mellitus, Herbal, food supplement