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

Clinical Trials

Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

Phase 4

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin
Drug: Exenatide 2 MG

First Posted Date: 2019-07-23

Last Posted Date: 2019-07-23

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 80

Registration Number: NCT04029272

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

Study of Exenatide Once-Weekly Suspension in Chinese Patients With Type 2 Diabetes Mellitus

Phase 1

Withdrawn

Conditions: Type 2 Diabetes

Interventions: Drug: Exenatide Once-Weekly Suspension

First Posted Date: 2019-06-28

Last Posted Date: 2020-06-04

Lead Sponsor: AstraZeneca

Registration Number: NCT04001231

Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Exenatide 2 MG
Drug: Dapagliflozin 10 MG

First Posted Date: 2019-05-31

Last Posted Date: 2021-08-30

Lead Sponsor: Consano Clinical Research, LLC

Target Recruit Count: 67

Registration Number: NCT03970044

Locations: 🇺🇸
Consano Clinical Research, LLC, Shavano Park, Texas, United States

Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

Phase 2

Completed

Conditions: Pre Diabetes

Interventions: Drug: Exenatide SR

First Posted Date: 2019-05-23

Last Posted Date: 2022-10-28

Lead Sponsor: Mayo Clinic

Target Recruit Count: 9

Registration Number: NCT03961256

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Haemodynamic Effects of GLP-1 and Glucagon in Healthy Male Volunteers

Not Applicable

Completed

Conditions: Cardiovascular Diseases

Interventions: Drug: Saline 0.9%
Drug: Glucagon (25ng/kg/min)
Drug: Exenatide
Drug: Glucagon (50ng/kg/min)

First Posted Date: 2019-02-08

Last Posted Date: 2024-04-03

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 26

Registration Number: NCT03835013

Locations: 🇬🇧
Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom

Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients

Phase 3

Conditions: Obesity

Interventions: Drug: Exenatide Microspheres for Injection
Drug: Exenatide
Drug: Liraglutide

First Posted Date: 2018-09-14

Last Posted Date: 2021-04-09

Lead Sponsor: Xiangya Hospital of Central South University

Target Recruit Count: 150

Registration Number: NCT03671733

Locations: 🇨🇳
Xiangya Hospital of Central South University, Changsha, Hunan, China

The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers

Phase 1

Terminated

Conditions: Alcohol Use Disorder

Interventions: Drug: Exenatide
Other: Sham injection

First Posted Date: 2018-08-24

Last Posted Date: 2022-02-09

Lead Sponsor: Boston Medical Center

Target Recruit Count: 8

Registration Number: NCT03645408

Locations: 🇺🇸
Boston University Psychiatry Research Center, Clinical Studies Unit, Boston, Massachusetts, United States

Effects of Exenatide on Motor Function and the Brain

Phase 1

Completed

Conditions: Parkinson's Disease

Interventions: Drug: Exenatide

First Posted Date: 2018-03-07

Last Posted Date: 2022-09-16

Lead Sponsor: University of Florida

Target Recruit Count: 5

Registration Number: NCT03456687

Locations: 🇺🇸
Laboratory for Rehabilitation Neuroscience, Gainesville, Florida, United States

Effect of Exenatide LAR or Dulaglutide on the Variability of 24-hour Heart Rate and Blood Pressure in Type 2 Diabetes

Phase 4

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Exenatide LAR
Drug: Dulaglutide

First Posted Date: 2018-02-23

Last Posted Date: 2020-03-26

Lead Sponsor: University of Guadalajara

Target Recruit Count: 30

Registration Number: NCT03444142

Locations: 🇲🇽
Instituto de terapeutica Experimental y Clinica. Centro universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, Mexico

The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients

Phase 3

Terminated

Conditions: Obesity
Diabetes Mellitus, Type 2

Interventions: Drug: Dapagliflozin 10mg
Drug: Placebo Oral Tablet
Drug: Exenatide 2 mg [Bydureon]
Drug: Placebo injection
Drug: Insulin
Drug: Metformin, if taken before

First Posted Date: 2018-02-05

Last Posted Date: 2020-03-31

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Target Recruit Count: 13

Registration Number: NCT03419624

Locations: 🇩🇪
University Medical Center Hamburg-Eppendorf, Hamburg, Germany
🇩🇪
Diabeteszentrum Oldenburg, Oldenburg, Lower Saxony, Germany
🇩🇪
Diabetologische Schwerpunktpraxis Harburg, Hamburg, Germany

and more 1 locations

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