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

An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2005-08-26
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
137
Registration Number
NCT00135330
Locations
🇺🇸

Research Site, Spokane, Washington, United States

Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2005-05-24
Last Posted Date
2015-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
456
Registration Number
NCT00111540
Locations
🇺🇸

Research Site, Spokane, Washington, United States

Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: placebo
First Posted Date
2005-02-18
Last Posted Date
2015-02-24
Lead Sponsor
AstraZeneca
Target Recruit Count
45
Registration Number
NCT00103935
Locations
🇺🇸

Research Site, Olympia, Washington, United States

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

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
First Posted Date
2004-12-13
Last Posted Date
2015-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
182
Registration Number
NCT00099320
Locations
🇪🇸

Research Site, Zaragoza, Spain

Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2004-12-13
Last Posted Date
2015-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
49
Registration Number
NCT00099333
Locations
🇺🇸

Research Site, San Antonio, Texas, United States

Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2004-11-25
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
69
Registration Number
NCT00097500
Locations
🇸🇪

Research Site, Goteborg, Sweden

Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo 0.04 mL once daily
Drug: Placebo 0.04 mL twice daily
Drug: Placebo 0.08 mL once daily
Drug: B - Exenatide 10 mcg twice daily
Drug: C - Exenatide 10 mcg once daily
First Posted Date
2004-06-22
Last Posted Date
2015-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
99
Registration Number
NCT00085969
Locations
🇺🇸

Mercury Street Medical Group, Butte, Montana, United States

🇺🇸

MedStar Research Institute, Washington, District of Columbia, United States

🇺🇸

Metrolina Medical Research, Charlotte, North Carolina, United States

and more 19 locations

Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2004-05-11
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
551
Registration Number
NCT00082381
Locations
🇺🇸

Internal Medicine Associates Department of Research, Fort Myers, Florida, United States

🇳🇱

Diabetes Centrum Bilthoven, Bilthoven, Netherlands

🇳🇱

Medisch Centrum, Westeinde, Netherlands

and more 84 locations

Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2004-05-10
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
505
Registration Number
NCT00082407
Locations
🇵🇹

Hospital Pedro Hispano, Matosinhos, Portugal

🇭🇷

Clinical Hospital Osijek, Osijek, Croatia

🇭🇷

Klinica bolnica Dubrava, Zagreb, Croatia

and more 66 locations

Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2002-09-05
Last Posted Date
2015-02-20
Lead Sponsor
AstraZeneca
Target Recruit Count
155
Registration Number
NCT00044668
Locations
🇭🇺

Uzsoki Street Municipal Hospital, Budapest, Hungary

🇭🇺

Peterfy Teaching Hospital, Budapest, Hungary

🇭🇺

Diagnostic Units Hungary Kft., Budapest, Hungary

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