CLINICAL TRIALS PROFILE FOR BYDUREON BCISE
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505(b)(2) Clinical Trials for BYDUREON BCISE
| 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for BYDUREON BCISE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00103935 ↗ | Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes | Completed | Eli Lilly and Company | Phase 2 | 2005-02-01 | Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus. |
| NCT00103935 ↗ | Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes | Completed | AstraZeneca | Phase 2 | 2005-02-01 | Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus. |
| NCT00308139 ↗ | Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1) | Completed | AstraZeneca | Phase 3 | 2006-04-01 | A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications. |
| NCT00877890 ↗ | A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5) | Completed | Eli Lilly and Company | Phase 3 | 2009-03-01 | This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability. |
| NCT00877890 ↗ | A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5) | Completed | AstraZeneca | Phase 3 | 2009-03-01 | This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability. |
| NCT01089569 ↗ | Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine | Completed | International Diabetes Center at Park Nicollet | N/A | 2010-04-01 | The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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