CLINICAL TRIALS PROFILE FOR GLYBURIDE
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All Clinical Trials for GLYBURIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00035542 ↗ | A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes. | Completed | Bristol-Myers Squibb | Phase 3 | 2001-12-01 | The purpose of this clinical research study is to see if Glucovance, a medication currently approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and effectively in children 9 to 16 years of age. |
| NCT00035568 ↗ | A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes | Completed | Bristol-Myers Squibb | Phase 4 | 2002-02-01 | The purpose of this clinical research study is to support earlier observations that Glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes. |
| NCT00046462 ↗ | Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment | Completed | Sanofi | Phase 3 | 2001-11-01 | The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination. |
| NCT00123643 ↗ | Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients | Completed | GlaxoSmithKline | Phase 4 | 2003-05-01 | The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients. |
| NCT00123643 ↗ | Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients | Completed | St. Paul Heart Clinic | Phase 4 | 2003-05-01 | The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients. |
| NCT00160485 ↗ | Glyburide Compared to Insulin in the Management of White's Classification A2 Gestational Diabetes | Withdrawn | Tripler Army Medical Center | Phase 4 | 2004-06-01 | The purpose of this study is to determine whether the oral administration of glyburide is as effective as insulin in the treatment of gestational diabetes. 1. SYNOPSIS: Infants born to mothers with gestational diabetes(GDM) are at risk for a variety of adverse perinatal outcomes including macrosomia with subsequent birth trauma and cesarean delivery, neonatal hypoglycemia, polycythemia, jaundice, hypocalcemia, respiratory depression and newborn intensive care unit admission. These adverse outcomes are thought to be related to the degree of maternal hyperglycemia during pregnancy. Women with GDM are typically treated with insulin to lower blood glucose levels to as near-normal as possible. A single randomized trial has suggested that the oral sulfonylurea, glyburide is a clinically effective and safe alternative to insulin therapy. 2. Many obstetric care providers have adopted the use of glyburide in the routine management of gestational diabetes. The American College of Obstetrics and Gynecology and the American Diabetic Association both state that further studies are needed in a larger patient population before the use of newer oral hypoglycemic agents can be supported for use in pregnancy. 3. STATUS: Previous studies have demonstrated that there is no maternal-fetal transfer of glyburide and when compared to insulin is an effective alternative to insulin. Additionally, a published cost analysis concluded that glyburide is significantly less costly than insulin for the treatment of GDM. The benefits of an oral agent for the management of gestational diabetes include less discomfort for the patient in drug administration, lower requirement for patient education in the administration of injectable medications and less chance of error in dosing. Our study population is more ethnically diverse and our incidence of large for gestational age infants is lower than in the largely Hispanic population studied by Langer et al. Many obstetricians, including ourselves, apply different criteria than Langer for diagnosing gestational diabetes , and for deciding when to institute insulin therapy. It is our goal to confirm the prior single study concerning the safety and efficacy of glyburide in reducing the complications of GDM utilizing a more ethnically diverse population with more realistic goals in glycemic control. To this end we will add to the medical literature supporting this alternative therapy to insulin. |
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