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Byetta, Exenatide

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jun 30, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

Byetta, Exenatide · 1 trial · 1 indication

Phase 2 1
NCT00747968The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PETType 2 Diabetes
COMPLETED8 Analytics
PHASE2COMPLETED
The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo.
oct. 2008 - oct 2010
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
glp-1-analogueACTIVE_COMPARATORDuring hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be heart OR CNS-PET scanned
placeboPLACEBO_COMPARATORDuring hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be CNS OR heart-PET scanned.

Interventions

NameTypeDescription
Byetta, ExenatideDRUGDrug: Exenatide or placebo Dosage form: Infusion Dosage: Exenatide (Eli Lilly/Amylin Pharmaceuticals) 0.066 pmol\*kg-1\*min-1 Duration: 5 hours Frequency: Drug given once, placebo given once
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Eligibility Criteria

Age Range50 Years to 70 Years
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Informed consent signed * Caucasian * Male * Diabetes for \> 6 months * Diet treatment or a single OAD (metformin, SU) * Age \> 50 years and \< 70 years * BMI 20-45 kg/m² * Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11% inclusive. * Fasting PG 7...

Countries:Denmark
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Frequently asked questions about Byetta, Exenatide

What is Byetta (exenatide) used for?

Byetta (exenatide) is used for the treatment of Type 2 Diabetes. It is a small molecule being developed by Eli Lilly and Company. The drug is currently in Phase 2 clinical development for this indication, and it is considered investigational, meaning it has not yet been approved for use.

How does Byetta (exenatide) work?

Byetta (exenatide) works as a GLP-1 analogue, which means it mimics the action of the naturally occurring hormone GLP-1. This mechanism is being studied for its effects on Type 2 Diabetes, particularly in the central nervous system and heart during hyperglycemia, as assessed in clinical trials.

Who makes Byetta (exenatide)?

Byetta (exenatide) is developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes.

What phase is Byetta (exenatide) in?

Byetta (exenatide) is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of Type 2 Diabetes, and its clinical trial program is ongoing.

What clinical trials is Byetta (exenatide) in?

Byetta (exenatide) has been studied in a Phase 2 clinical trial with the identifier NCT00747968. This completed trial, titled "The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET," enrolled 8 male participants aged 50 years and older in Denmark. The trial was randomized, double-blind, and placebo-controlled.

Is Byetta the same as exenatide?

Yes, Byetta is the same as exenatide. Byetta is a brand name, and exenatide is the generic name for the drug. Both names refer to the same medication being developed by Eli Lilly and Company for the treatment of Type 2 Diabetes.