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| Sponsor: | Takeda Global Research & Development Center, Inc. |
|---|---|
| Collaborator: |
Takeda Pharmaceuticals North America, Inc. |
| Information provided by: | Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00521742 |
Purpose
The purpose of this study is to evaluate the cardiovascular effects of pioglitazone, once daily (QD), versus glyburide when administered to patients with type 2 diabetes mellitus and mild cardiac disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Pioglitazone Drug: Glyburide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Comparator-Controlled Study of Pioglitazone HCl vs Glyburide in the Treatment of Patients With Type 2 (Non-Insulin-Dependent) Diabetes Mellitus and Mild Cardiac Disease (NYHA I) |
| Enrollment: | 300 |
| Study Start Date: | March 2001 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pioglitazone 15 mg to 45 mg QD |
Drug: Pioglitazone
Pioglitazone 15 mg to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 52 weeks.
Other Names:
|
| Active Comparator: Glyburide 2.5 mg to 15 mg, QD |
Drug: Glyburide
Glyburide 2.5 mg to 15 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
|
| Experimental: Pioglitazone 15 mg or 30 mg QD |
Drug: Pioglitazone
Pioglitazone 15 mg or 30 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally once daily for up to 52 weeks.
Other Names:
|
| Active Comparator: Glyburide 5 mg or 10 mg, QD |
Drug: Glyburide
Glyburide 5 mg or 10 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally once daily for up to 52 weeks.
|
Diabetes is a chronic disease involving multiple metabolic defects that include inadequate insulin activity and resultant hyperglycemia. Individuals' differing genetic predisposition, level of physical activity, and age all contribute to variations in the onset and severity of type 2 diabetes. However, progression of this disease typically follows a characteristic pattern that begins as a reduced sensitivity of hepatic and peripheral-tissues to circulating insulin (ie, insulin resistance). The body's decreasing ability to produce adequate insulin to overcome insulin resistance (ie, insulin deficiency due to beta-cell insufficiency) results in impaired glucose tolerance and ultimately overt diabetes. In the United States, an estimated 17 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 and resultant dialysis or renal transplantation, neuropathy, and nontraumatic amputations. Intensive glucose management in the early stages of diabetes may help forestall complications.
Pioglitazone is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. Glyburide, is an oral antidiabetic agent of the sulfonylurea class. The primary purpose of this study is to evaluate the cardiovascular effects of pioglitazone versus glyburide when administered to patients with type 2 diabetes mellitus and mild cardiac disease
Study participation is anticipated to be approximately 1 year and 2 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
Any of the following:
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Contacts and Locations| Study Director: | VP Clinical Science Strategy | Takeda Global Research and Developmnet Center Inc |
More Information
| Responsible Party: | Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00521742 History of Changes |
| Other Study ID Numbers: | 01-00-TL-OPI-520, U1111-1114-1616 |
| Study First Received: | August 25, 2007 |
| Last Updated: | April 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes |
Diabetes Mellitus, Lipoatrophic Dyslipidemia Drug Therapy |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Cardiovascular Diseases Pioglitazone Glyburide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |