Status:
COMPLETED
Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Type 2 Diabetes Mellitus
Obese
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.
Eligibility Criteria
Inclusion
- Body mass index (BMI) \>/= 27 kg/m2
- HbA1c between 7.5% and 10.5% (inclusive)
- C-Peptide (fasting) greater than or equal to 500 pmol/L
- On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for \>/= 3 months prior to screening, and remain on stable dose throughout the study
- Agree to conduct home-based (fasted) blood glucose testing as directed
Exclusion
- Clinically significant abnormalities in medical history or physical exam
- Serum creatinine \> ULN at Screening
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST \> 1.5x ULN at Screening
- History of renal transplantation or renal dialysis
- GFR \< 60 mL/min at Screening
- History of diabetic ketoacidosis
- History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- Allergy to sulfur containing drugs
- Treatment with other drugs or medications not allowed per study specific Disallowed Concomitant Medicines
- 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 :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01918865
Start Date
August 1 2013
End Date
February 1 2015
Last Update
March 3 2015
Active Locations (21)
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1
Isis Investigative Site
Mar del Plata, Buenos Aires, Argentina, B7600FZN
2
Isis Investigative Site
Rosario, Santa Fe Province, Argentina, S2000CVD
3
Isis Investigational Site
Edmonton, Alberta, Canada, T6G 2E1
4
Isis Investigational Site
Kelowna, British Columbia, Canada, V1Y 3G8