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

Status:	Completed
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 75
Updated:	11/23/2013
Start Date:	July 2013
End Date:	February 2015
Contact:	Isis Pharmaceuticals
Email:	patients@isisph.com
Phone:	+1-800-679-4747

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

We found this trial at

sites

Isis Investigational Site

Oklahoma City, Oklahoma 73103

157

from

Oklahoma City, OK