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

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Diabetes Type 2

Interventions: Drug: Exenatide once weekly suspension
Drug: Sitagliptin
Drug: Placebo

First Posted Date: 2012-07-30

Last Posted Date: 2015-08-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 365

Registration Number: NCT01652729

Locations: 🇺🇸
Research Site, Spokane, Washington, United States
🇺🇸
Reseach Site, Rapid City, South Dakota, United States

Weight Loss With Exenatide Treatment

Phase 4

Completed

Conditions: Obesity

Interventions: Drug: Placebo
Drug: Exenatide
Behavioral: Dietary counseling

First Posted Date: 2012-05-03

Last Posted Date: 2021-06-23

Lead Sponsor: Jody Dushay

Target Recruit Count: 249

Registration Number: NCT01590433

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Acute Effect of Exenatide on Brain Glucose Metabolism

Phase 4

Completed

Conditions: Impaired Glucose Tolerance (IGT)
Diabetes

Interventions: Drug: Exenatide
Drug: Placebo

First Posted Date: 2012-05-01

Last Posted Date: 2017-11-24

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Target Recruit Count: 15

Registration Number: NCT01588418

Locations: 🇺🇸
Texas Diabetes Institute and UTHSCSA, San Antonio, Texas, United States

Myocardial Protection of Exenatide in AMI

Phase 4

Completed

Conditions: Myocardial Infarction

Interventions: Drug: exenatide BYETTA® (Amylin-Lilly)
Drug: Saline

First Posted Date: 2012-04-19

Last Posted Date: 2012-04-19

Lead Sponsor: Kyunghee University Medical Center

Target Recruit Count: 127

Registration Number: NCT01580514

Locations: 🇰🇷
Kyung Hee University Hospital, Seoul, Korea, Republic of

Pharmacology of Exenatide in Pediatric Sepsis

Phase 1

Withdrawn

Conditions: Organ Dysfunction
Inflammation
Septic Shock
Glucose Homeostasis
Health-related Quality of Life

Interventions: Drug: Exenatide
Drug: Exenatide vehicle

First Posted Date: 2012-04-10

Last Posted Date: 2017-10-05

Lead Sponsor: Seattle Children's Hospital

Registration Number: NCT01573806

Locations: 🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States

Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Phase 3

Completed

Conditions: Children and Adolescent With Type 2 Diabetes

Interventions: Drug: Exenatide Once Weekly
Drug: Placebo

First Posted Date: 2012-03-15

Last Posted Date: 2021-11-30

Lead Sponsor: AstraZeneca

Target Recruit Count: 84

Registration Number: NCT01554618

Locations: 🇺🇦
Research Site, Odesa, Ukraine

FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Insulin Glargine
Drug: Metformin
Drug: Prandial insulin
Drug: Exenatide

First Posted Date: 2012-02-02

Last Posted Date: 2023-12-29

Lead Sponsor: University of Washington

Target Recruit Count: 102

Registration Number: NCT01524705

Locations: 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
Joslin Diabetes Center, Boston, Massachusetts, United States
🇺🇸
University of Washington, Seattle, Washington, United States

and more 9 locations