Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Exclusion Criteria

• •1. Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.
• •2. Subjects with a family history of diabetes in a first degree relative
• •3. BMI of less than 24 or greater than 40 kg/m2
• •4. Unstable body weight (change of greater than ±4lbs over the preceding 3 months
• •5. Subjects participating in an excessively heavy exercise program
• •6. Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
• •7. Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded.
• •8. Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
• •9. Pregnant subjects or subjects unwilling to use birth control during their study enrollment
• •10. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening.
• •11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
• •12. Subjects with hematuria will be excluded.
• •13. Subjects with evidence or prior history of heart failure will be excluded
• •14. Subjects with family history of pancreatic, bladder, and breast cancer will be excluded.
• •15. Subjects with history of pancreatitis will be excluded.
• •16. Subjects with eGFR \< 60 ±5 ml/min.1.73m2 will be excluded.
• •17. Subjects with elevated serum creatinine (\>1.5 mg/dl males/1.4 mg/dl females) will be excluded.
• •18. Subjects with a history of orthostatic hypotension (\>15/10 mmHg) will be excluded.
• •19. Subjects with liver enzymes (ALT, AST) \>3-fold above upper normal limit will be excluded.
• •20. Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded.