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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT02583919

Run by

Ionis Pharmaceuticals, Inc.

People needed

79

Starts

2015-09-01

Expected to finish

2017-05-11

Last updated by the study team

2018-06-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ionis Investigational Site — Greenbrae, California, United States
• Ionis Investigational Site — Huntington Park, California, United States
• Ionis Investigational Site — La Mesa, California, United States
• Ionis Investigational Site — Los Angeles, California, United States
• Isis Investigational Site — Spring Valley, California, United States
• Ionis Investigational Site — Port Orange, Florida, United States
• Ionis Investigational Site — Marietta, Georgia, United States
• Ionis Investigational Site — Oxon Hill, Maryland, United States
• Ionis Investigational Site — New York, New York, United States
• Ionis Investigational Site — Greensboro, North Carolina, United States
• Ionis Investigational Site — Morehead City, North Carolina, United States
• Ionis Investigational Site — Cincinnati, Ohio, United States
• Ionis Investigational Site — Cincinnati, Ohio, United States
• Ionis Investigational Site — Eugene, Oregon, United States
• Ionis Investigational Site — Spartanburg, South Carolina, United States
• Ionis Investigational Site — Houston, Texas, United States
• Ionis Investigational Site — Houston, Texas, United States
• Ionis Investigational Site — Katy, Texas, United States
• Ionis Investigational Site — Olympia, Washington, United States

Full record on ClinicalTrials.gov

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