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

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Phase 2
Terminated
Conditions
Diabetes Mellitus
Interventions
Drug: placebo
First Posted Date
2008-06-19
Last Posted Date
2015-04-10
Lead Sponsor
AstraZeneca
Target Recruit Count
80
Registration Number
NCT00701935
Locations
🇨🇦

Research Site, Quebec, Canada

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2008-05-13
Last Posted Date
2015-04-09
Lead Sponsor
AstraZeneca
Target Recruit Count
820
Registration Number
NCT00676338
Locations
🇬🇧

Research Site, Swansea, United Kingdom

🇮🇱

Research SIte, Tel-Hashomer, Israel

Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2008-05-06
Last Posted Date
2015-02-24
Lead Sponsor
AstraZeneca
Target Recruit Count
70
Registration Number
NCT00672399
Locations
🇬🇧

Reseach Site, Derriford, Plymouth, United Kingdom

🇬🇧

Research Site, Leeds, West Yorkshire, United Kingdom

How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: placebo
First Posted Date
2008-04-28
Last Posted Date
2013-02-06
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
41
Registration Number
NCT00667732
Locations
🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

Medstar Research Institute, Washington DC, District of Columbia, United States

Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: Placebo
First Posted Date
2008-04-14
Last Posted Date
2020-12-01
Lead Sponsor
AstraZeneca
Target Recruit Count
122
Registration Number
NCT00658021
Locations
🇿🇦

Research Site, Verulam, South Africa

Role of Exenatide in NASH-a Pilot Study

Phase 2
Completed
Conditions
Nonalcoholic Fatty Liver Disease
Interventions
First Posted Date
2008-04-01
Last Posted Date
2017-04-11
Lead Sponsor
Indiana University
Target Recruit Count
8
Registration Number
NCT00650546
Locations
🇺🇸

Indiana University, Indianapolis, Indiana, United States

🇺🇸

Kansas City VA Medical Center, Kansas City, Missouri, United States

🇺🇸

Fort Sam Houston, San Antonio, Texas, United States

Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2008-03-21
Last Posted Date
2015-06-15
Lead Sponsor
AstraZeneca
Target Recruit Count
467
Registration Number
NCT00641056
Locations
🇨🇳

Research Site, Taoyuan, Taiwan

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: placebo tablet
Drug: placebo once weekly
First Posted Date
2008-03-17
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
514
Registration Number
NCT00637273
Locations
🇲🇽

Research Site, Toluca, Mexico

CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy

Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection
First Posted Date
2008-03-13
Last Posted Date
2015-04-09
Lead Sponsor
AstraZeneca
Target Recruit Count
2515
Registration Number
NCT00635492
Locations
🇸🇪

Research Site, Vastervik, Sweden

🇩🇪

Research, Birkenfeld, Germany

Bioenergetic Alterations After Exenatide Administration

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-02-26
Last Posted Date
2015-01-09
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
28
Registration Number
NCT00623545
Locations
🇺🇸

Univ Wisconsin Hospital and Clinics, Madison., Wisconsin, United States

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