Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes

• Status: Completed
• Trial end date: 2017-05-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with 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 ≥ 25.0 kg/m2 < 36.0 kg/m2

• HbA1c ≥ 7.5% and ≤ 10.5%

• Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed

• 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

• History of liver transplantation 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, SU or DPPIV 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 -