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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Criteria

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