DeepMed Research

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

Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2
Non-alcoholic Fatty Liver Disease

Interventions: Drug: Exenatide
Drug: insulin glargine

First Posted Date: 2014-12-01

Last Posted Date: 2019-08-28

Lead Sponsor: Fudan University

Target Recruit Count: 76

Registration Number: NCT02303730

Locations: 🇨🇳
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China
🇨🇳
Department of Endocrinology and Metabolism, Shanghai Minhang Central Hospital, Shanghai, Shanghai, China
🇨🇳
Department of Endocrinology and Metabolism,Huadong Hospital, Shanghai, Shanghai, China

and more 2 locations

GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration

Phase 1

Completed

Conditions: Cocaine Dependence

Interventions: Drug: cocaine hydrochloride
Drug: placebo
Drug: exenatide

First Posted Date: 2014-11-27

Last Posted Date: 2023-02-16

Lead Sponsor: Yale University

Target Recruit Count: 13

Registration Number: NCT02302976

Locations: 🇺🇸
Connecticut Mental Health Center, New Haven, Connecticut, United States

Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Bydureon
Drug: Placebo

First Posted Date: 2014-11-11

Last Posted Date: 2017-01-27

Lead Sponsor: AstraZeneca

Target Recruit Count: 239

Registration Number: NCT02288273

Locations: 🇺🇸
Research Site, Olympia, Washington, United States

Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease
Left Ventricular Diastolic Dysfunction

Interventions: Drug: BYDUREON
Drug: Placebo

First Posted Date: 2014-09-29

Last Posted Date: 2023-05-17

Lead Sponsor: Baylor Research Institute

Target Recruit Count: 57

Registration Number: NCT02251431

Locations: 🇺🇸
Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital, Dallas, Texas, United States

Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

Phase 3

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Exenatide matching placebo
Drug: Exenatide

First Posted Date: 2014-09-01

Last Posted Date: 2019-01-08

Lead Sponsor: AstraZeneca

Target Recruit Count: 464

Registration Number: NCT02229383

Locations: 🇿🇦
Research Site, Worcester, South Africa

Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Basal insulin and exenatide
Drug: Basal insulin only
Drug: Basal insulin and bolus insulin

First Posted Date: 2014-07-18

Last Posted Date: 2022-04-11

Lead Sponsor: Mount Sinai Hospital, Canada

Target Recruit Count: 105

Registration Number: NCT02194595

Locations: 🇨🇦
Mount Sinai Hospital, Toronto, Ontario, Canada

GLP-1 Agonism Stimulates Browning of Subcutaneous White Adipose Tissue in Obesity Men

Phase 4

Completed

Conditions: Obesity

Interventions: Drug: Placebo
Drug: Exenatide

First Posted Date: 2014-06-23

Last Posted Date: 2017-01-18

Lead Sponsor: Xiang Guang-da

Target Recruit Count: 20

Registration Number: NCT02170324

Locations: 🇨🇳
Wuhan General Hospital, Wuhan, Hubei, China

Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus

Phase 4

Conditions: Type 2 Diabetes

Interventions: Drug: Bydureon
Drug: placebo

First Posted Date: 2014-06-12

Last Posted Date: 2018-06-14

Lead Sponsor: Phoenix VA Health Care System

Target Recruit Count: 148

Registration Number: NCT02162550

Locations: 🇺🇸
Phoenix VA Health Care System, Phoenix, Arizona, United States

Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying

Phase 4

Completed

Conditions: Obesity

Interventions: Drug: Placebo
Drug: Exenatide

First Posted Date: 2014-06-11

Last Posted Date: 2016-08-09

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT02160990

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

Liver and Fat Regulation in Overweight Adolescent Girls

Phase 2

Completed

Conditions: Obesity
Polycystic Ovarian Syndrome
Hepatic Steatosis

Interventions: Drug: Byetta 5Mcg Pen Injection

First Posted Date: 2014-06-06

Last Posted Date: 2024-06-04

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 92

Registration Number: NCT02157974

Locations: 🇺🇸
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado, Aurora, Colorado, United States

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