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

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Diabetes Mellitus, Herbal, food 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
Sites / Locations
- Laniado Hospital, Diabetes Unit
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
DbXell
Placebo
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.
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.