Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
Over the past 30 years, the prevalence of diabetes has increased dramatically throughout the
world due to population growth, aging, urbanization, increasing obesity, and physical
inactivity. The total number of people with type 2 diabetes mellitus is projected to rise
from 171 million in 2000 to 366 million in 2030. The incidence of type 2 diabetes mellitus
in the United States alone is expected to increase from approximately 17 to 30.3 million by
the year 2030. Type 2 diabetes mellitus is associated with a number of long-term
microvascular and macrovascular complications associated with a reduced quality of life and
increased morbidity and mortality. It is anticipated that the increasing incidence of type 2
diabetes mellitus will place an ever-increasing burden on families, increase national
expenditures for health care services, and decrease worker productivity.
Current pharmacologic interventions for type 2 diabetes mellitus include a diverse range of
antidiabetic medications with different mechanisms of action including insulin and insulin
analogues, sulfonylureas, metformin, meglitinides, thiazolidinediones, inhibitors of
alpha-glucosidase, analogs of glucagon-like peptide-1 and synthetic analogues of human
amylin. Despite the variety of medications, many have clinically important or potentially
life-threatening side effects, restricted use in many subpopulations, concerns with
long-term tolerability, and challenges related to compliance due to side effects and route
of administration. All of these reasons contribute to the difficulties patients have
achieving the target glycosylated hemoglobin level less than 7%.
SYR-322 (alogliptin) is a selective, orally available inhibitor of the dipeptidyl
peptidase-4 enzyme. Dipeptidyl peptidase-4 enzyme is thought to be primarily responsible for
the in vivo degradation of 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 beta cells to stimulate glucose-dependent insulin secretion
as well as regulating beta cell proliferation and cytoprotection. Glucagon-like peptide-1,
but not glucose-dependent insulinotropic peptide, inhibits gastric emptying, glucagon
secretion, and food intake. Glucose-dependent insulinotropic peptide has been shown to
enhance insulin secretion by direct interaction with a glucose-dependent insulinotropic
peptide -specific receptor on islet beta cells. The glucose-lowering actions of
glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved in
patients with type 2 diabetes mellitus.
Pioglitazone (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd.
(Osaka, Japan) that is approved for the treatment of type 2 diabetes mellitus. Pioglitazone
is a selective peroxisome proliferator-activated receptor-gamma agonist that decreases
insulin resistance in the periphery and liver resulting in increased insulin-dependent
glucose disposal and decreased hepatic glucose output.
Given the complementary mechanisms of action of alogliptin (stimulation of insulin
secretion) and pioglitazone (enhancement of insulin sensitivity), the goal of this study is
to evaluate the efficacy of the combination of alogliptin with pioglitazone in patients who
are inadequately controlled on metformin. Study participation is anticipated to be
approximately 7 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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