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

Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy

Phase 4

Conditions: Type 2 Diabetes

Interventions: Drug: Exenatide
Drug: Metformin

First Posted Date: 2014-05-02

Last Posted Date: 2014-05-02

Lead Sponsor: xiaolong zhao

Target Recruit Count: 100

Registration Number: NCT02129985

Locations: 🇨🇳
Xiaolong Zhao, Jingan, Shanghai, China

A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Exenatide extended-release
Drug: Placebo
Drug: LY2944876
Drug: Metformin

First Posted Date: 2014-04-22

Last Posted Date: 2021-05-27

Lead Sponsor: OPKO Health, Inc.

Target Recruit Count: 420

Registration Number: NCT02119819

Locations: 🇺🇸
Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, United States
🇷🇴
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Timisoara, Romania
🇵🇷
Manati Medical Center, Manati, Puerto Rico

and more 31 locations

Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status

Not Applicable

Conditions: Obesity

Interventions: Drug: Exenatide

First Posted Date: 2014-04-21

Last Posted Date: 2014-04-21

Lead Sponsor: Shanghai 10th People's Hospital

Target Recruit Count: 20

Registration Number: NCT02118376

Locations: 🇨🇳
Shanghai Tenth People' Hospital, Shanghai, Shanghai, China

Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

Phase 4

Completed

Conditions: Prediabetes
Obesity

Interventions: Drug: Exenatide
Drug: Saxagliptin
Other: Placebo
Drug: Exenatide extended-release (ER)

First Posted Date: 2014-04-04

Last Posted Date: 2018-07-03

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 21

Registration Number: NCT02104739

Locations: 🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States

Safety Evaluation of Adverse Reactions in Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Linagliptin
Drug: Exenatide
Drug: Gliclazide

First Posted Date: 2014-03-20

Last Posted Date: 2018-02-07

Lead Sponsor: Charles University, Czech Republic

Target Recruit Count: 42

Registration Number: NCT02092597

Locations: 🇨🇿
General University Hospital, Prague, Czechia

Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

Completed

Conditions: Diabetes Mellitus Type 2

Interventions: Drug: Exenatide

First Posted Date: 2014-03-18

Last Posted Date: 2015-08-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 1711

Registration Number: NCT02090673

Locations: 🇰🇷
Local Institution, Seoul, Korea, Republic of

Exenatide and Weight Loss for Diabetes Prevention

Phase 1

Completed

Conditions: Pre Diabetes
Insulin Resistance

Interventions: Drug: placebo
Drug: Exenatide 5 and 10 mcg 2 times a day

First Posted Date: 2014-03-12

Last Posted Date: 2016-11-04

Lead Sponsor: Stanford University

Target Recruit Count: 66

Registration Number: NCT02084654

A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)

Phase 4

Terminated

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Metformin
Drug: Glimepiride
Drug: Pioglitazone
Drug: Acarbose
Drug: Linagliptin
Drug: Sitagliptin
Drug: Liraglutide
Drug: Exenatide once weekly (QW)
Drug: Insulin Glargine
Drug: Exenatide twice daily (BID)

First Posted Date: 2014-02-26

Last Posted Date: 2019-10-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 192

Registration Number: NCT02072096

Locations: 🇺🇸
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, United States
🇺🇸
Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, United States
🇺🇸
Carolina Health Specialists, Myrtle Beach, South Carolina, United States

and more 16 locations