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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01885260

Run by

Ionis Pharmaceuticals, Inc.

People needed

77

Starts

2013-07-01

Expected to finish

2014-11-01

Last updated by the study team

2016-07-04

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 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

You may not qualify if…

• 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

Where it is running

• Isis Investigational Site — Birmingham, Alabama, United States
• Isis Investigational Site — Muscle Shoals, Alabama, United States
• Isis Investigational Site — Anaheim, California, United States
• Isis Investigational Site — Chino, California, United States
• Isis Investigational Site — Los Angeles, California, United States
• Isis Investigational Site — DeLand, Florida, United States
• Isis Investigational Site — Fort Lauderdale, Florida, United States
• Isis Investigational Site — Miami, Florida, United States
• Isis Investigational Site — Marietta, Georgia, United States
• Isis Investigational Site — Las Vegas, Nevada, United States
• Isis Investigational Site — Cincinnati, Ohio, United States
• Isis Investigational Site — Oklahoma City, Oklahoma, United States
• Isis Investigational Site — Eugene, Oregon, United States
• Isis Investigational Site — Corpus Christi, Texas, United States
• Isis Investigational Site — Katy, Texas, United States
• Isis Investigational Site — Salt Lake City, Utah, United States
• Isis Investigational Site — Renton, Washington, United States
• Isis Investigational Site — Spokane, Washington, United States
• Isis Investigational Site — Lenasia South, Gauteng, South Africa
• Isis Investigational Site — Soweto, Gauteng, South Africa
• Isis Investigational Site — Durban, KwaZulu-Natal, South Africa
• Isis Investigational Site — Cape Town, Western Cape, South Africa
• Isis Investigational Site — Parow, Cape Town, Western Cape, South Africa
• Isis Investigational Site — Western Cape, Western Cape, South Africa

Full record on ClinicalTrials.gov

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