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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR BYDUREON PEN

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505(b)(2) Clinical Trials for Bydureon Pen

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 Not yet recruiting University of Washington Phase 3 2020-09-01 Childhood obesity and related long-term effects are serious public health problems, but not all obese children 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 Not yet recruiting Seattle Children's Hospital Phase 3 2020-09-01 Childhood obesity and related long-term effects are serious public health problems, but not all obese children 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 Pen

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.
NCT01554618 Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes Recruiting AstraZeneca Phase 3 2016-05-01 The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes.
NCT01664624 Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes Completed Takeda Phase 1 2012-07-01 The purpose of this study is to assess the effect of roflumilast plus alogliptin on glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bydureon Pen

Condition Name

Condition Name for Bydureon Pen
Intervention Trials
Type 2 Diabetes 7
Type 2 Diabetes Mellitus 5
Obesity 4
Diabetes Mellitus, Type 2 3
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Condition MeSH

Condition MeSH for Bydureon Pen
Intervention Trials
Diabetes Mellitus, Type 2 16
Diabetes Mellitus 13
Obesity 5
Atherosclerosis 2
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Clinical Trial Locations for Bydureon Pen

Trials by Country

Trials by Country for Bydureon Pen
Location Trials
United States 127
China 2
Kuwait 2
Denmark 2
Sweden 2
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Trials by US State

Trials by US State for Bydureon Pen
Location Trials
Texas 9
Florida 8
California 8
New York 7
Washington 7
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Clinical Trial Progress for Bydureon Pen

Clinical Trial Phase

Clinical Trial Phase for Bydureon Pen
Clinical Trial Phase Trials
Phase 4 12
Phase 3 9
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Bydureon Pen
Clinical Trial Phase Trials
Recruiting 17
Completed 10
Not yet recruiting 4
[disabled in preview] 3
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Clinical Trial Sponsors for Bydureon Pen

Sponsor Name

Sponsor Name for Bydureon Pen
Sponsor Trials
AstraZeneca 8
Seattle Children's Hospital 2
Vanderbilt University 2
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Sponsor Type

Sponsor Type for Bydureon Pen
Sponsor Trials
Other 32
Industry 13
U.S. Fed 2
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