MedPath

Exenatide

Generic Name
Exenatide
Brand Names
Bydureon, Byetta
Drug Type
Biotech
CAS Number
141758-74-9
Unique Ingredient Identifier
9P1872D4OL
Background

Exenatide is a glucagon-like peptide-1 (GLP-1) analog. It activates the GLP-1 receptor and increases insulin secretion, decreases glucagon secretion, and slows gastric emptying to improve glycemic control. Exenatide was given FDA approval on April 28, 2005. It is available as immediate- and extended-release formulations. Bydureon, the brand name product of extended-release exenatide in an injectable suspension, was discontinued in 2021. Bydureon BCise, an auto-injector extended-release formulation, remains available.

Indication

Exenatide is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. An extended-release formulation is available which is indicated in patients ≥10 years old, while the immediate-acting formulation is approved only for adult patients.

Associated Conditions
Type 2 Diabetes Mellitus

A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes

Phase 1
Terminated
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-12-25
Last Posted Date
2019-10-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
60
Registration Number
NCT02020616
Locations
🇺🇸

Orange County Research Center, Orange, California, United States

🇺🇸

Compass Research, Orlando, Florida, United States

🇺🇸

Clinilabs, Inc (New York), New York, New York, United States

and more 2 locations

Trial of Exenatide for Parkinson's Disease

Phase 2
Completed
Conditions
Parkinson's Disease
Interventions
Other: Placebo
First Posted Date
2013-10-29
Last Posted Date
2016-11-17
Lead Sponsor
University College, London
Target Recruit Count
60
Registration Number
NCT01971242
Locations
🇬🇧

National Hospital for Neurology & Neurosurgery (part of UCLH NHS Trust), London, United Kingdom

Exenatide for Stress Hyperglycemia

Phase 2
Completed
Conditions
Stress Hyperglycemia
Interventions
First Posted Date
2013-10-25
Last Posted Date
2017-10-06
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Target Recruit Count
110
Registration Number
NCT01969149
Locations
🇫🇷

Post operative intensive care unit of the cardiac surgery department, Besançon, France

Effect of Exenatide on Liver and Heart Fat and Inflammation

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-09-26
Last Posted Date
2016-05-16
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
24
Registration Number
NCT01951651
Locations
🇺🇸

Baylor College of Medicine, Houston, Texas, United States

Exenatide for Myocardial Protection During Reperfusion Study

Phase 2
Conditions
Myocardial Infarction
Interventions
Drug: Placebo
First Posted Date
2013-09-10
Last Posted Date
2016-08-05
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
198
Registration Number
NCT01938235
Locations
🇨🇦

Institut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval), Quebec City, Quebec, Canada

🇨🇦

Toronto General Hospital, University Health Network, Toronto, Ontario, Canada

🇨🇦

Southlake Regional Health Centre, Newmarket, Ontario, Canada

and more 7 locations

A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

Phase 2
Completed
Conditions
Type I Diabetes
Interventions
First Posted Date
2013-08-23
Last Posted Date
2020-03-19
Lead Sponsor
Yale University
Target Recruit Count
79
Registration Number
NCT01928329
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

and more 5 locations

Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2013-06-24
Last Posted Date
2019-06-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
813
Registration Number
NCT01885208
Locations
🇬🇧

Novo Nordisk Investigational Site, Rotherham, United Kingdom

An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-06-13
Last Posted Date
2015-02-24
Lead Sponsor
AstraZeneca
Target Recruit Count
275
Registration Number
NCT01876849
Locations
🇺🇸

Research Site, Renton, Washington, United States

Feasibility Study of Exenatide by Continuous Subcutaneous Infusion

Phase 1
Completed
Conditions
Obesity
Interventions
First Posted Date
2013-05-20
Last Posted Date
2017-10-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
10
Registration Number
NCT01857895
Locations
🇺🇸

GSK Investigational Site, Baltimore, Maryland, United States

Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes

Phase 1
Completed
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2013-05-16
Last Posted Date
2016-07-07
Lead Sponsor
Yale University
Target Recruit Count
17
Registration Number
NCT01855490
Locations
🇺🇸

Yale School of Medicine, New Haven, Connecticut, United States

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