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
11
sites
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