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Last Updated: November 26, 2024

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CLINICAL TRIALS PROFILE FOR BYDUREON BCISE


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505(b)(2) Clinical Trials for bydureon bcise

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 >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 >Phase >Start Date >Summary

Clinical Trial Conditions for bydureon bcise

Condition Name

Condition Name for bydureon bcise
Intervention Trials
Type 2 Diabetes 8
Type 2 Diabetes Mellitus 6
Obesity 4
Diabetes Mellitus, Type 2 4
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Condition MeSH

Condition MeSH for bydureon bcise
Intervention Trials
Diabetes Mellitus, Type 2 18
Diabetes Mellitus 14
Obesity 5
Parkinson Disease 2
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Clinical Trial Locations for bydureon bcise

Trials by Country

Trials by Country for bydureon bcise
Location Trials
United States 136
China 2
Mexico 2
Kuwait 2
Denmark 2
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Trials by US State

Trials by US State for bydureon bcise
Location Trials
Texas 12
California 8
Florida 8
New York 7
Washington 7
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Clinical Trial Progress for bydureon bcise

Clinical Trial Phase

Clinical Trial Phase for bydureon bcise
Clinical Trial Phase Trials
Phase 4 13
Phase 3 10
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for bydureon bcise
Clinical Trial Phase Trials
Completed 23
Recruiting 6
Unknown status 4
[disabled in preview] 5
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Clinical Trial Sponsors for bydureon bcise

Sponsor Name

Sponsor Name for bydureon bcise
Sponsor Trials
AstraZeneca 9
The University of Texas Health Science Center, Houston 4
Seattle Children's Hospital 2
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Sponsor Type

Sponsor Type for bydureon bcise
Sponsor Trials
Other 40
Industry 15
NIH 2
[disabled in preview] 2
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