Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.
• NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects
‣ Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening.
⁃ FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl
⁃ BMI = 24-40 kg/m2;
⁃ Stable body weight (±4lbs) over the preceding 3 months
⁃ Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
⁃ Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):
• Oral contraceptive
∙ Injectable progesterone
∙ Subdermal implant
∙ Spermicidal foam/gel/film/cream/suppository
∙ Diaphragm with spermicide
∙ Copper or hormonal containing IUD
∙ Sterile male partner vasectomized \> 6 month pre-dosing.
⁃ Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
⁃ Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.