Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes

Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes Being Treated With Metformin

The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo

Inclusion Criteria:

• Male or female, age 18 to 75
• BMI ≥ 25.0 kg/m2
• HbA1c ≥ 8.0% and ≤ 10.5%
• Type 2 Diabetes Mellitus and on stable dose of Metformin
• Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

• Clinically significant abnormalities in medical history of physical exam
• Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
• History of solid organ transplant or renal dialysis
• History of liver disease
• History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
• Treatment with any other antidiabetic drug(s) other than metformin within 3 months of screening
• History of diabetic ketoacidosis
• Any other significant illness or condition that may interfere with the patient participating or completing the study
• Inability or unwillingness to comply with protocol or study procedures