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

A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Ranolazine
Drug: Placebo
Drug: Exenatide

First Posted Date: 2013-04-30

Last Posted Date: 2014-03-31

Lead Sponsor: Gilead Sciences

Target Recruit Count: 24

Registration Number: NCT01843127

Locations: 🇺🇸
Profil Institute for Clinical Research, Inc., Chula Vista, California, United States
🇺🇸
Translational Research Institute-Florida Hospital, Orlando, Florida, United States
🇺🇸
SeaView Research, Inc, Miami, Florida, United States

Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome

Phase 4

Withdrawn

Conditions: Short Bowel Syndrome

Interventions: Drug: Placebo
Drug: Exenatide

First Posted Date: 2013-03-26

Last Posted Date: 2014-01-14

Lead Sponsor: Mayo Clinic

Registration Number: NCT01818648

Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

Phase 3

Completed

Conditions: Obesity
Metabolic Syndrome X
Drug-induced Obesity
Schizophrenia

Interventions: Drug: Placebo
Drug: Exenatide

First Posted Date: 2013-02-18

Last Posted Date: 2015-06-24

Lead Sponsor: Bjorn H. Ebdrup

Target Recruit Count: 45

Registration Number: NCT01794429

Locations: 🇩🇰
Cnsr/Cins, Glostrup, Denmark

Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults

Phase 4

Terminated

Conditions: Human Immunodeficiency Virus Infection
Diabetes Mellitus

Interventions: Drug: extended-release exenatide

First Posted Date: 2013-02-15

Last Posted Date: 2017-03-10

Lead Sponsor: Vanderbilt University

Target Recruit Count: 6

Registration Number: NCT01791465

Locations: 🇺🇸
Vanderbilt University, Nashville, Tennessee, United States

Extension Study for 2993-112

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: AC2993

First Posted Date: 2013-02-12

Last Posted Date: 2015-02-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 225

Registration Number: NCT01789957

Locations: 🇺🇸
Diabetes, Endocrine and Nutrition Center, Bangor, Maine, United States
🇺🇸
Metabolic Research Institute, Inc., West Palm Beach, Florida, United States
🇺🇸
St. Agnes Health Care, Baltimore, Maryland, United States

and more 209 locations