ESSENS-HYPERGLYCEMIA TRIAL

STUDY POPULATION
  • INCLUSION CRITERIA
  • Male or Female aged ≥ 18 years to ≤ 65 years
  • New Diagnosed:
    Newly diagnosed with higher than normal blood sugar levels i.e. Fasting Plasma Glucose of >100 mg/dl, as defined by ADA expert committee on the diagnosis and classification of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment.
  • Informed consent:
    Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures.
  • EXCLUSION CRITERIA
  • Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
  • Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
  • Impaired renal function as shown by but not limited to Serum Creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
  • Clinical evidence of active liver disease or serum alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
  • Pregnancy or lactating women
  • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol