Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 2, Multi Center, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, PK, & Activity of ISIS 113715 Administered Weekly in Subjects With Type 2 DM Treated w/ Sulfonylurea
The purpose of this study is to provide an initial assessment of the safety, tolerability and efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects.
Diabetes is a significant and growing world-wide medical burden. Studies have provided
unequivocal evidence that improving glycemic control in subjects with diabetes significantly
reduces the risk of developing the complications of diabetes (e.g., retinopathy,
nephropathy, and neuropathy). Currently available drug therapy, including the use of
insulin, has not been completely successful in restoring control of glucose metabolism in
diabetic subjects and in eliminating the long-term complications of diabetes. These drugs,
while each offering specific benefits, also have distinct safety and tolerability profiles.
Thus, there remains a need for agents with novel mechanism(s) of action.
ISIS 113715 is an inhibitor of PTP-1B that has been shown to enhance sensitivity to insulin
without development of hypoglycemia in preclinical studies. Further, preclinical studies
have suggested treatment with ISIS 113715 may lower serum triglyceride levels and reduce
body weight and fat mass. Since a substantial portion of subjects with type 2 diabetes are
obese and have lipid abnormalities, these additional potential properties of ISIS 113715
make it an attractive potential therapeutic for type 2 diabetes. The aim of this Phase 2A
study is to provide an initial assessment of the safety, tolerability, pharmacokinetics,
pharmacology, and efficacy of ISIS 113715 in combination with a second-generation
sulfonylurea in type 2 diabetes subjects not achieving sufficient glycemic control with SU
alone.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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