Status:
COMPLETED
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx in combination with metformin versus placebo + metformin
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01885260
Start Date
July 1 2013
End Date
November 1 2014
Last Update
July 4 2016
Active Locations (24)
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1
Isis Investigational Site
Birmingham, Alabama, United States, 35216
2
Isis Investigational Site
Muscle Shoals, Alabama, United States, 35662
3
Isis Investigational Site
Anaheim, California, United States, 92801
4
Isis Investigational Site
Chino, California, United States, 91710