CLINICAL TRIALS PROFILE FOR EXENATIDE
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505(b)(2) Clinical Trials for EXENATIDE
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Combination | NCT04520490 ↗ | Brain Activation and Satiety in Children 2 | Recruiting | University of Washington | Phase 3 | 2021-01-28 | Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children. |
| New Combination | NCT04520490 ↗ | Brain Activation and Satiety in Children 2 | Recruiting | Seattle Children's Hospital | Phase 3 | 2021-01-28 | Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children. |
| New Formulation | NCT05347147 ↗ | A Phase III Trial to Determine the Efficacy and Safety of Presendin in IIH | Not yet recruiting | Premier Research International LLC | Phase 3 | 2022-06-01 | Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH. |
| New Formulation | NCT05347147 ↗ | A Phase III Trial to Determine the Efficacy and Safety of Presendin in IIH | Not yet recruiting | Invex Therapeutics Ltd. | Phase 3 | 2022-06-01 | Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for EXENATIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00082381 ↗ | Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin | Completed | Eli Lilly and Company | Phase 3 | 2003-06-01 | This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c). |
| NCT00082381 ↗ | Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin | Completed | AstraZeneca | Phase 3 | 2003-06-01 | This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c). |
| NCT00082407 ↗ | Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin | Completed | Eli Lilly and Company | Phase 3 | 2003-11-01 | This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c). |
| NCT00082407 ↗ | Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin | Completed | AstraZeneca | Phase 3 | 2003-11-01 | This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c). |
| NCT00085969 ↗ | Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus | Completed | Eli Lilly and Company | Phase 2 | 2003-09-01 | The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus. |
| NCT00085969 ↗ | Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus | Completed | AstraZeneca | Phase 2 | 2003-09-01 | The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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