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

Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

Phase 1

Completed

Conditions: Hyperinsulinemic Hypoglycemia

Interventions: Drug: Exenatide
Drug: Acarbose
Drug: Exenatide Placebo
Drug: Acarbose Placebo

First Posted Date: 2016-02-19

Last Posted Date: 2021-05-06

Lead Sponsor: University of Minnesota

Target Recruit Count: 11

Registration Number: NCT02685852

Locations: 🇺🇸
University of Minnesota Medical Center, Minneapolis, Minnesota, United States

GLP-1 and Hyperoxia for Organ Protection in Heart Surgery

Not Applicable

Active, not recruiting

Conditions: Stroke
Aortic Valve Disease
Shock, Cardiogenic
Brain Injury
Coronary Disease
Renal Failure

Interventions: Drug: Conoxia (AGA, oxygen)
Drug: Byetta (Lilly, Exenatide)
Drug: 20% Human Albumin

First Posted Date: 2016-02-04

Last Posted Date: 2024-08-28

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 1400

Registration Number: NCT02673931

Locations: 🇩🇰
Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark

Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity

Phase 3

Completed

Conditions: Hypothalamic Obesity

Interventions: Drug: placebo
Drug: Exenatide

First Posted Date: 2016-01-27

Last Posted Date: 2022-05-05

Lead Sponsor: Seattle Children's Hospital

Target Recruit Count: 42

Registration Number: NCT02664441

Locations: 🇺🇸
Seattle Childrens, Seattle, Washington, United States
🇺🇸
Children's Hospitals adn Clinics of Minnesota, Minneapolis, Minnesota, United States
🇺🇸
Vanderbilt University School of Medicine, Nashville, Tennessee, United States

Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

Phase 1

Completed

Conditions: Healthy Adult Male and Female Volunteers

Interventions: Drug: Placebo
Drug: Exenatide
Drug: Moxifloxacin
Drug: Palonosetron

First Posted Date: 2016-01-08

Last Posted Date: 2017-01-27

Lead Sponsor: Intarcia Therapeutics

Target Recruit Count: 82

Registration Number: NCT02650479

Locations: 🇳🇱
PRA-Groningen, Groningen, Netherlands

EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)

Phase 3

Completed

Conditions: Obesity
Polycystic Ovary Syndrome

Interventions: Drug: Exenatide once weekly (EQW )
Drug: Dapagliflozin plus Glucophage (MET ER)
Drug: Phentermine /Topiramate (PHEN/ TPM) ER
Drug: Dapagliflozin (DAPA)
Drug: EQW plus DAPA

First Posted Date: 2015-12-18

Last Posted Date: 2021-01-29

Lead Sponsor: Woman's

Target Recruit Count: 119

Registration Number: NCT02635386

Locations: 🇺🇸
Woman's Hospital, Baton Rouge, Louisiana, United States

Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects

Phase 4

Completed

Conditions: Restenosis
Diabetes
Atherosclerosis

Interventions: Drug: Bydureon
Drug: Humulin kwickpen
Drug: Metformin

First Posted Date: 2015-12-03

Last Posted Date: 2023-04-20

Lead Sponsor: Karolinska Institutet

Target Recruit Count: 38

Registration Number: NCT02621489

Locations: 🇸🇪
Dept of clinical science and education Karolinska Institutet Södersjukhuset, Stockholm, Other, Sweden

Diabetes Islet Preservation Immune Treatment

Phase 1

Withdrawn

Conditions: Autoimmune Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia

Interventions: Drug: Anti-Thymocyte Globulin (ATG)
Other: ATG Placebo
Other: IL-2 Placebo
Drug: Interleukin 2
Other: Adalimumab Placebo
Drug: Exenatide
Other: Exenatide Placebo
Drug: Adalimumab