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

Status:	Completed
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 75
Updated:	6/27/2018
Start Date:	September 2015
End Date:	May 11, 2017

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

We found this trial at

sites

Ionis Investigational Site

Oxon Hill, Maryland 20745

from

Oxon Hill, MD