The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Western Galilee Medical Center - Nahariya
Nahariya, Israel
Kaplan Medical Center
Rehovot, Israel
ZIV Hospital
Evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous dosages in combination with OAD versus OAD + placebo.
Examine the effect of treatment with 15 and 30 mg/day ISIS 113715 on fasting plasma glucose and HbA1c.
Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin.
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Safed, Israel