MedPath

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

A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2009-04-08
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
254
Registration Number
NCT00877890
Locations
🇺🇸

Research Site, Tacoma, Washington, United States

The Effects of Exenatide After Gastric Restriction

Phase 2
Conditions
Morbid Obesity
Interventions
Drug: Placebo
First Posted Date
2009-03-31
Last Posted Date
2009-03-31
Lead Sponsor
Advanced Specialty Care
Target Recruit Count
28
Registration Number
NCT00872378
Locations
🇺🇸

Endocrinology Services NorthWest, Bend, Oregon, United States

🇺🇸

Advanced Specialty Care, Bend, Oregon, United States

A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2009-03-27
Last Posted Date
2015-04-09
Lead Sponsor
AstraZeneca
Target Recruit Count
255
Registration Number
NCT00870194
Locations
🇲🇽

Research Site, Tampico, Mexico

The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

Phase 3
Completed
Conditions
Weight Loss
Obesity
Interventions
Other: Metabolic Chamber
Behavioral: Weight loss
Drug: Placebo
First Posted Date
2009-03-06
Last Posted Date
2019-06-04
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
150
Registration Number
NCT00856609
Locations
🇺🇸

NIDDK, Phoenix, Phoenix, Arizona, United States

Evaluation of Exenatide in Patients With Diabetic Neuropathy

Not Applicable
Completed
Conditions
Diabetic Peripheral Neuropathy
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2009-03-04
Last Posted Date
2017-03-01
Lead Sponsor
University of Michigan
Target Recruit Count
46
Registration Number
NCT00855439
Locations
🇺🇸

The University of Michigan Health System, Ann Arbor, Michigan, United States

Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults

Phase 4
Completed
Conditions
Weight Gain
Interventions
Drug: Placebo
First Posted Date
2009-02-18
Last Posted Date
2018-04-20
Lead Sponsor
University of Cincinnati
Target Recruit Count
54
Registration Number
NCT00845507
Locations
🇺🇸

University of Cincinnati, Cincinnati, Ohio, United States

The Effects of Exenatide on Post-Meal Sugar Peaks and Vascular Health in Obese/Pre-Diabetic Young Adults

Phase 4
Withdrawn
Conditions
Obesity
Cardiovascular Disease
Insulin Resistance
Impaired Glucose Tolerance
Interventions
First Posted Date
2009-02-18
Last Posted Date
2012-12-11
Lead Sponsor
Yale University
Registration Number
NCT00845559

Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function

Phase 4
Completed
Conditions
Healthy
Impaired Glucose Tolerance
Type 2 Diabetes
Interventions
First Posted Date
2009-02-18
Last Posted Date
2018-01-18
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
43
Registration Number
NCT00845182
Locations
🇺🇸

Barter Research Center, ALM VA Hospital, San Antonio, Texas, United States

Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

Phase 4
Completed
Conditions
Myocardial Infarction
Interventions
Drug: Saline
First Posted Date
2009-02-04
Last Posted Date
2015-05-05
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
100
Registration Number
NCT00835848
Locations
🇩🇰

Heart Center, Rigshospitalet, Copenhagen, Denmark

Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure

Phase 4
Terminated
Conditions
Heart Failure, Diastolic
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-11-27
Last Posted Date
2020-09-04
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
2
Registration Number
NCT00799435
Locations
🇺🇸

Baylor College of Medicine, Houston, Texas, United States

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