Diabetes Mellitus Clinical Trial
Official title:
A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.
SYR-322 (alogliptin) is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl
peptidase IV is thought to be primarily responsible for the degradation of 2 peptide
hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and
glucose-dependent insulinotropic peptide. It is expected that inhibition of dipeptidyl
peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes
mellitus by prolonging the beneficial effects of glucagon-like peptide-1.
The rising incidence of type 2 diabetes mellitus and the limitations of the currently
available treatments suggest the need for new therapies for glycemic control. Studies have
been undertaken in humans that evaluated the effects of directly augmenting glucagon-like
peptide-1 and glucose-dependent insulinotropic peptide levels and of inhibiting the activity
of dipeptidyl peptidase IV.
This study is an extension of 7 controlled phase 3 studies of alogliptin. These phase 3
studies included 1 monotherapy study of alogliptin (SYR-322-PLC-010; NCT00286455); 4
placebo-controlled add-on studies of alogliptin, namely in combination with a sulfonylurea
(SYR-322-SULF-007; NCT00286468), metformin (SYR-322-MET-008; NCT00286442), a
thiazolidinedione (pioglitazone; SYR-322-TZD-009; NCT00286494), and insulin
(SYR-322-INS-011; NCT00286429); 1 coadministration study with pioglitazone in combination
with metformin (01-05-TL-322OPI-001; NCT00328627), and 1 coadministration study with
pioglitazone (01-06-TL-322OPI-002; NCT00395512).
The end of treatment or early withdrawal visit from the preceding study will be the
screening visit for this study, after which enrolled patients will be required to commit to
approximately 22 additional visits at the study center.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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