Diabetes Mellitus Clinical Trial
Official title:
Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV
being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the
primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released
in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent
insulinotropic peptide.
Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries,
Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism
of action.
This study will assess the effects of alogliptin and alogliptin coadministered with
pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type
2 diabetes. Individuals who participate in this study will be required to commit to a
screening visit and up to 6 additional visits at the study center. Study participation is
anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur
at each visit which may include fasting, blood collection, urine collection, physical
examinations and electrocardiograms. At 3 of the visits a meal will be served that must be
eaten within 10 minutes.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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