Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes
Phase 2
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: PlaceboDrug: ISIS-GCCRRx
- Registration Number
- NCT01968265
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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
- Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
- History of diabetic ketoacidosis
- Current or previous diagnosis of Gilbert's disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo - ISIS-GCCRRx ISIS-GCCRRx -
- Primary Outcome Measures
Name Time Method The effect of ISIS-GCCRRx on serum fructosamine 7 Weeks Change from Baseline to Week 7
- Secondary Outcome Measures
Name Time Method The safety of ISIS-GCCRRx 18 Weeks By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
The tolerability of ISIS-GCCRRx 18 Weeks By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
Trial Locations
- Locations (2)
Isis Investigative Site
🇿🇦Somerset West, Western Cape, South Africa
Isis Investigative site
🇷🇴Bucharest, Romania