Uncontrolled diabetes mellitus: hemoglobin Ac (HbAc) must be < % or there must be documentation that control has been good for the week prior to study entry, with daily morning glucoses at < mg/dl; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by glycated hemoglobin (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > .% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by HbAc >% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary. Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus defined as hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus may be included; however, blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin (Hb)Ac > % despite adequate therapy; note: patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) greater than % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Patients with uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary EXPANSION COHORT ONLY: Uncontrolled diabetes mellitus as defined by HbAc > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin, alpha (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by glycated hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by hemoglobin Ac (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by glycated hemoglobin (HbAc) > % despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary Uncontrolled diabetes mellitus as defined by HbAc >% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary;