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Sponsors and Collaborators: |
Takeda Global Research & Development Centre (Europe) Ltd. Eli Lilly and Company |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00174993 |
The purpose of this study is to determine whether pioglitazone 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.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: Pioglitazone Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
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 |
Enrollment: | 4373 |
Study Start Date: | May 2001 |
Study Completion Date: | January 2005 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Pioglitazone
Pioglitazone 15 mg to 45 mg, tablets, orally, once daily for up to 48 months.
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2: Placebo Comparator |
Drug: Placebo
Pioglitazone placebo-matching tablets, orally, once daily for up to 48 months
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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.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Established history of macrovascular disease, defined as 1 or more of:
Exclusion Criteria
Study Director: | European Development Director | Takeda Global Research & Development Centre (Europe) Ltd. |
Responsible Party: | Takeda Global Research & Development Centre (Europe) Ltd. ( VP, Clinical Science ) |
Study ID Numbers: | AD4833/EC444 |
Study First Received: | September 9, 2005 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00174993 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Austria: Federal Ministry for Health and Women; Switzerland: Swissmedic; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Finland: National Agency for Medicines; Norway: Norwegian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Hungary: National Institute of Pharmacy; Slovakia: State Institute for Drug Control; Czech Republic: State Institute for Drug Control; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Estonia: The State Agency of Medicine |
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes; Diabetes Mellitus |
Lipoatrophic Dyslipidemia Drug Therapy |
Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |