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| Sponsored by: |
Takeda Global Research & Development Center, Inc. |
|---|---|
| Information provided by: | Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00225277 |
Purpose
The purpose of this study was to determine the efficacy of pioglitazone compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Pioglitazone Drug: Glimepiride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Randomized, Comparator-Controlled Study In Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus Glimepiride on the Rate of Progression of Coronary Atherosclerotic Disease as Measured by Intravascular Ultrasound |
| Enrollment: | 547 |
| Study Start Date: | July 2003 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Pioglitazone
Up to 45 mg pioglitazone (optimized for glucose control), tablets, orally, once daily for up to 18 months.
|
| 2: Active Comparator |
Drug: Glimepiride
Up to 4 mg of glimepiride (optimized for glucose control), tablets, orally, once daily for up to 18 months.
|
Diabetes is a chronic disease with multiple metabolic defects that result in hyperglycemia arising from inadequate insulin activity. Type 2 diabetes is usually the result of a progression from reduced sensitivity of hepatic and peripheral tissue cells to circulating insulin (ie, insulin resistance) to a progressive inability of the body to produce adequate insulin to overcome insulin resistance (ie, insulin deficiency due to beta-cell insufficiency) resulting in impaired glucose tolerance and ultimately overt diabetes. In the United States, an estimated 21 million people have diabetes, with type 2 diabetes occurring in approximately 90% to 95% of cases. The goal of treating type 2 diabetes is to control blood glucose and thereby prevent long-term complications. Adequate glycemic control is paramount in attempting to avert chronic complications, including blindness; renal dysfunction resulting in dialysis or renal transplantation; neuropathy; non-traumatic amputations; and macrovascular complications, including myocardial ischemia and myocardial infarction, stroke, and peripheral arterial disease. Intensive glucose management in the early stages of diabetes may help forestall such complications.
Therapeutic agents have been developed to address each of the major functional metabolic defects associated with type 2 diabetes: decreased beta-cell function, elevated hepatic glucose output, and insulin resistance. Thiazolidinediones increase glucose utilization, decrease gluconeogenesis, and increase glucose disposal by binding to nuclear receptors known as peroxisome proliferator-activated receptors. 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 without predisposing patients to hypoglycemia. Peroxisome proliferator-activated receptors 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.
This study was designed to compare the effects of pioglitazone compared to glimepiride on progression of atherosclerotic disease, as measured by intravascular ultrasound.
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Angiographic criteria:
Target Coronary Artery:
Exclusion Criteria:
Was required to take or intended to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may have interfered with evaluation of the study medication, including:
Contacts and Locations
Show 79 Study Locations| Study Director: | VP Clinical Science | Takeda Global Research & Development Center, Inc. |
More Information
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
| Study ID Numbers: | 01-01-TL-OPI-516 |
| Study First Received: | September 21, 2005 |
| Results First Received: | October 17, 2008 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00225277 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile |
|
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic |
Dyslipidemia Drug Therapy Atherosclerosis |
|
Atherosclerosis Metabolic Diseases Immunologic Factors Pioglitazone Diabetes Mellitus Disease Progression Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents |
Glimepiride Hypoglycemic Agents Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Dyslipidemias |
|
Metabolic Diseases Pioglitazone Immunologic Factors Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents |
Pharmacologic Actions Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Glucose Metabolism Disorders |