Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg Versus Dose Titration From 30 mg to 45 mg of Pioglitazone HCl (ACTOS®) in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of Metformin and 30 mg of Pioglitazone HCl Therapy
The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate glycemic control.
Despite the introduction of new classes of medications for glycemic control, just over half
of adults with type 2 diabetes mellitus (T2DM) achieve a glycosylated hemoglobin level less
than 7.0%, the American Diabetes Association recommended glycosylated hemoglobin goal. The
rising incidence of type 2 diabetes mellitus along with limitations of the currently
available treatments suggest the need for new therapies for glycemic control along with the
increased requirement for combination therapy in type 2 diabetes mellitus.
Thiazolidinediones increase glucose utilization, decrease gluconeogenesis, and increase
glucose disposal through an incompletely understood mechanism but one associated with
binding of the drug to nuclear receptors known as peroxisome proliferator-activated
receptors-gamma. Peroxisome proliferator-activated receptors-gamma are found in tissues
important for insulin action, such as adipose tissue, skeletal muscle, and the liver. The
greatest concentration of peroxisome proliferator-activated receptors-gamma receptors is in
adipose tissue. Thiazolidinediones reduce insulin resistance by enhancing insulin
sensitivity in muscle cells, adipose tissue, and hepatic cells (inhibiting hepatic
gluconeogenesis) with no direct impact on insulin secretion. Thus, thiazolidinediones
improve glycemic control and result in reduced levels of circulating insulin. Pioglitazone
HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka,
Japan). Pioglitazone depends on the presence of insulin for its mechanism of action.
Worldwide clinical investigation has shown that, as an adjunct to diet and exercise,
pioglitazone improves glycemic control when used as monotherapy, and in combination with
commonly used antidiabetic medications (ie, sulfonylureas, metformin, or insulin).
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV
currently in development by Takeda Global Research & Development Center, Inc. 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. Both
peptides exert important effects on islet β-cells to stimulate glucose-dependent insulin
secretion and regulate β-cell proliferation and cytoprotection. Glucagon-like peptide-1 also
inhibits gastric emptying, glucagon secretion, and food intake. The glucose-lowering actions
of glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved
in patients with type 2 diabetes.
Given the complementary mechanisms of action of alogliptin (stimulation of insulin
secretion) and pioglitazone (enhancement of insulin sensitivity) and the absence of
overlapping safety risks, the introduction of this combination therapy in patients with T2DM
could potentially show enhanced glycemic control and allow patients to reach and maintain
their HbA1c goal more effectively.
This study is designed to determine if the addition of alogliptin to a combination of
pioglitazone with metformin can be effective at achieving glycemic control without
increasing safety risks versus the titration of pioglitazone to 45 mg with metformin in
patients with type 2 diabetes mellitus who are experiencing inadequate glycemic control on a
current regimen of metformin.
;
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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