Diabetes Mellitus Clinical Trial
Official title:
PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy
The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.
Diabetes mellitus is one of the most common non-communicable diseases worldwide. More than
22 million persons have been diagnosed with diabetes in the European region of the
International Diabetes Federation. Complications of diabetes involving both microvascular
and macrovascular systems contribute to increased disability and reduced life expectancy.
Damage to the coronary, cerebral (brain), and peripheral vascular beds as a consequence of
diabetes is responsible for the increased macrovascular illness and death associated with
the disease.
Insulin resistance is common to the genesis of both atherosclerosis and type 2 diabetes
mellitus. In diabetes, insulin resistance is coupled to receptor dysfunction. In
atherosclerosis, insulin resistance may have both direct effects on the cardiovascular
system as well as indirect effects provoked by imbalances in blood glucose, lipids, clotting
factors, endothelial function, and other factors. Considerable indirect evidence suggests
that peroxisome proliferator-activated receptor agonists may favorably influence
macrovascular outcome, either through modification of risk factors (such as blood lipids) or
through effects on the vessel wall.
Pioglitazone, a thiazolidinedione compound discovered by Takeda Pharmaceutical Company, Ltd,
functions as a peroxisome proliferator-activated receptor agonist as its mode of action.
This study is designed to assess whether pioglitazone in combination with other medications
administered for glycemic management of type 2 diabetes might reduce the incidence of
macrovascular events associated with this disease compared with placebo. Individuals who
participate in this study will provide written informed consent and will be required to
commit to screening and randomization visits and approximately 17 additional visits (1 every
2 months for the first year and every 3 months thereafter) at the study center. Study
participation is anticipated to be about 40 months (or approximately 3 years and 4 months).
Multiple procedures will occur at each visit which may include fasting, blood collection,
physical examinations and electrocardiograms.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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