Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels

Inclusion Criteria:

1. Age ≥ 18 years to ≤ 65 years

2. Newly diagnosed Male or Female participants with higher than normal blood sugar levels (FPG >100 mg/dL) on of Pre-Diabetes and Diabetes Mellitus during screening and not onany treatment

3. Ability to understand and willingness to sign and date a written Informed ConsentDocument at the screening visit before any protocol- specific procedures are performedand willing to adhere to the protocol and entire trial procedures

Exclusion Criteria:

1. Subjects with Type 1 Diabetes Mellitus

2. Participants on insulin therapy and other oral anti-diabetic agents or havinguncontrolled diabetes.

3. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneoustransluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.

4. Cardiac status New York Heart Association class III-IV

5. Uncontrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic

6. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dlfor males and ≥ 1.4 mg/dl for female

7. Clinically significant peripheral edema

8. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) oraspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 XULN)

9. Participants on steroid

10. Pregnancy or lactating women

11. Known hypersensitivity to any of the study drugs

12. Any malignancy within the last 5 years, with exception of adequately treated basal orsquamous cell carcinoma of the skin or adequately treated carcinoma insitu.

13. Current addiction or current alcohol abuse or history of substance or alcohol abusewithin the last 2 years

14. Subject is the investigator or any sub-investigator, research assistant, pharmacist,study coordinator, other staff or relative thereof directly involved in the conduct ofthe protocol

15. Mental condition rendering the subject unable to understand the nature, scope andpossible consequences of the study. Subject unlikely to comply with protocol e.g.uncooperative attitude, inability to return for follow up visits and unlikelihoodcompleting of the study.

16. Any disease or condition that in the opinion of the investigator and/or sponsor mayinterfere with the completion of the study.