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

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: exenatide
Drug: insulin glargine

First Posted Date: 2006-08-04

Last Posted Date: 2015-04-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 235

Registration Number: NCT00360334

Locations: 🇬🇧
Research Site, Wirral, United Kingdom

Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: exenatide

First Posted Date: 2006-08-03

Last Posted Date: 2015-02-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 377

Registration Number: NCT00359879

Locations: 🇲🇽
Research Site, San Luis Potosi, Mexico

Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: exenatide
Drug: glimepiride

First Posted Date: 2006-08-02

Last Posted Date: 2015-09-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 1029

Registration Number: NCT00359762

Locations: 🇬🇧
Research Site, Wiltshire, United Kingdom

The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Glargine Insulin
Drug: Exenatide

First Posted Date: 2006-07-19

Last Posted Date: 2018-01-09

Lead Sponsor: Joslin Diabetes Center

Target Recruit Count: 72

Registration Number: NCT00353834

Locations: 🇺🇸
Joslin Diabetes Center, Boston, Massachusetts, United States

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: exenatide

First Posted Date: 2006-05-11

Last Posted Date: 2015-02-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 466

Registration Number: NCT00324363

Locations: 🇨🇳
Research Site, Taipei, Taiwan

Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

Phase 3

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

First Posted Date: 2006-04-11

Last Posted Date: 2017-01-06

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 373

Registration Number: NCT00313001

Locations: 🇺🇸
Novo Nordisk Investigational Site, Plainsboro, New Jersey, United States

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: exenatide, long acting release
Drug: exenatide

First Posted Date: 2006-03-29

Last Posted Date: 2015-08-26

Lead Sponsor: AstraZeneca

Target Recruit Count: 303

Registration Number: NCT00308139

Locations: 🇨🇦
Research Site, Toronto, Ontario, Canada
🇺🇸
Research Site 023, Butte, Montana, United States
🇺🇸
Research Site 518, San Diego, California, United States

and more 20 locations