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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
92
Isis Investigative Site
Mar del Plata, Buenos Aires, Argentina
Isis Investigative Site
Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
Time frame: 38 weeks
Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
Time frame: 27 weeks
Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy
Time frame: 27 Weeks
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Rosario, Santa Fe Province, Argentina
Isis Investigational Site
Edmonton, Alberta, Canada
Isis Investigational Site
Kelowna, British Columbia, Canada
Isis Investigational Site
Vancouver, British Columbia, Canada
Isis Investigational Site
Etobicoke, Ontario, Canada
Isis Investigational Site
Toronto, Ontario, Canada
Isis Investigative Site
Toronto, Ontario, Canada
Isis Investigational Site
Saskatoon, Saskatchewan, Canada
Isis Investigational Site
Benoni, Benoni, South Africa
...and 11 more locations