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 Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: placebo
First Posted Date
2007-08-14
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
54
Registration Number
NCT00516074
Locations
🇳🇱

Research Site, Utrecht, Netherlands

Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2007-07-27
Last Posted Date
2009-03-16
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
36
Registration Number
NCT00508287
Locations
🇺🇸

Elite Research Institute, Miami, Florida, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

New Orleans Center For Clinical Research, Knoxville, Tennessee, United States

A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

Phase 2
Completed
Conditions
Obesity
Interventions
Drug: placebo
First Posted Date
2007-07-12
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
163
Registration Number
NCT00500370
Locations
🇵🇷

Research Site, San Juan, Puerto Rico

A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2007-05-23
Last Posted Date
2015-08-26
Lead Sponsor
AstraZeneca
Target Recruit Count
102
Registration Number
NCT00477581
Locations
🇺🇸

Research Site, San Antonio, Texas, United States

The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women

Phase 4
Completed
Conditions
Obesity
Impaired Glucose Tolerance
Interventions
Drug: Placebo
First Posted Date
2007-04-05
Last Posted Date
2017-09-11
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
41
Registration Number
NCT00456885
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Role of Exenatide in Type 1 Diabetes

Phase 2
Completed
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2007-04-04
Last Posted Date
2019-02-26
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
11
Registration Number
NCT00456300
Locations
🇺🇸

Texas Children's Hospital/ Baylor College of Medicine, Houston, Texas, United States

Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: premixed insulin aspart twice daily (BID)
First Posted Date
2007-02-14
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
494
Registration Number
NCT00434954
Locations
🇩🇪

Research Site, Wolfsburg, Germany

A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2006-09-28
Last Posted Date
2015-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
153
Registration Number
NCT00382239
Locations
🇯🇵

Research Site, Tokyo, Japan

Safety and Efficacy of Exenatide as Monotherapy

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: placebo
First Posted Date
2006-09-27
Last Posted Date
2015-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
233
Registration Number
NCT00381342
Locations
🇷🇺

Research Site, St. Petersburg, Russian Federation

Effect on Weight Loss of Exenatide Versus Placebo

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: placebo
First Posted Date
2006-09-13
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
196
Registration Number
NCT00375492
Locations
🇺🇸

Research Site, Renton, Washington, United States

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