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 ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

Phase 3
Withdrawn
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2011-10-20
Last Posted Date
2012-12-25
Lead Sponsor
Intarcia Therapeutics
Registration Number
NCT01455922
Locations
🇺🇸

Intarcia Therapeutics, Inc, Hayward, California, United States

A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
Other: ITCA placebo
First Posted Date
2011-10-20
Last Posted Date
2015-08-18
Lead Sponsor
Intarcia Therapeutics
Target Recruit Count
460
Registration Number
NCT01455857
Locations
🇺🇸

Study Site, Spokane, Washington, United States

🇺🇸

Intarcia, Hayward, California, United States

A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
Other: ITCA placebo
First Posted Date
2011-10-20
Last Posted Date
2017-01-27
Lead Sponsor
Intarcia Therapeutics
Target Recruit Count
4156
Registration Number
NCT01455896
Locations
🇺🇸

Study SIte, San Diego, California, United States

🇺🇸

Study Site, San Antonio, Texas, United States

🇺🇸

Intarcia Therapeutics, Inc, Hayward, California, United States

Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome

Not Applicable
Completed
Conditions
Prader-Willi Syndrome
Interventions
First Posted Date
2011-10-03
Last Posted Date
2016-09-29
Lead Sponsor
Children's Hospital Los Angeles
Target Recruit Count
10
Registration Number
NCT01444898
Locations
🇺🇸

Children's Hospital of Los Angeles, Los Angeles, California, United States

Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes

Phase 4
Conditions
Type 2 Diabetes
Interventions
Procedure: Gastric Bypass
First Posted Date
2011-09-19
Last Posted Date
2015-03-27
Lead Sponsor
Wu Qinan
Target Recruit Count
60
Registration Number
NCT01435980
Locations
🇨🇳

Endocrine Department, the south west Hospital of the Third Military Medical University, Chongqing, Chongqing, China

Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2011-09-13
Last Posted Date
2016-04-12
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
24
Registration Number
NCT01432405
Locations
🇺🇸

Baylor College of Medicine, Houston, Texas, United States

Impact of Exenatide on Sleep Duration

Completed
Conditions
Type 2 Diabetes
First Posted Date
2011-08-15
Last Posted Date
2023-04-26
Lead Sponsor
University of Chicago
Target Recruit Count
8
Registration Number
NCT01416649
Locations
🇺🇸

The University of Chicago, Chicago, Illinois, United States

Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist

Phase 4
Terminated
Conditions
Bone Remodeling
Type 2 Diabetes Mellitus
Interventions
Drug: Saline
First Posted Date
2011-06-27
Last Posted Date
2017-06-14
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
14
Registration Number
NCT01381926
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass

Phase 3
Completed
Conditions
Coronary Artery Disease
Decreased Left Ventricular Function
Interventions
First Posted Date
2011-06-14
Last Posted Date
2016-02-02
Lead Sponsor
Charles University, Czech Republic
Target Recruit Count
38
Registration Number
NCT01373216
Locations
🇨🇿

General University Hospital, Prague, Czech Republic

Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes

Not Applicable
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: Placebo
First Posted Date
2011-06-02
Last Posted Date
2023-07-12
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
23
Registration Number
NCT01364584
Locations
🇺🇸

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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