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

A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus 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 + metformin

Inclusion Criteria:

• Male or female, age 18 to 75
• BMI greater than or equal to 25
• HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
• Type 2 Diabetes Mellitus and on stable dose of oral metformin
• Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

• Clinically significant abnormalities in medical history or physical exam
• Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
• History of renal transplantation or renal dialysis
• History of liver disease
• History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
• Use of oral anti-diabetic medication 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