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exenatide twice daily

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: Apr 7, 2015

exenatide twice daily development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Apr 2009

exenatide twice daily target and mechanism

Molecular targetGLP1R
Target classAgonist
ModalitySmall molecule

Also known as exenatide twice daily (BID)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment494

FDA Designations

No designations recorded

exenatide twice daily clinical trials

exenatide twice daily · 1 trial · 1 indication

Phase 3 1
NCT00434954Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED494 Analytics
PHASE3COMPLETED
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Glycosylated Hemoglobin (HbA1c)
Baseline and 26 weeks

Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)

Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
26 weeks

Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26

Secondary Endpoints

Percentage of Subjects Achieving HbA1c Target of < 6.5%
26 weeks
Percentage of Subjects Achieving HbA1c Target of < 7.0%
26 weeks
Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)
26 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Exenatide Twice Daily (BID)EXPERIMENTAL -
Premixed Insulin Aspart Twice Daily (BID)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
exenatide twice daily (BID)DRUGsubcutaneous injection (5 mcg or 10 mcg), twice a day
premixed insulin aspart twice daily (BID)DRUGsubcutaneous injection (titrated appropriately), twice a day
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * Have not received thiazo...

Countries:Germany
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Frequently asked questions about exenatide twice daily

What is exenatide twice daily used for?

Exenatide twice daily is used to treat Type 2 Diabetes Mellitus. It is a GLP1R agonist developed by AstraZeneca PLC (ticker AZN). The drug is in Phase 3 clinical development and has been studied in a completed Phase 3 trial comparing it with insulin aspart, both added to metformin, in patients with Type 2 Diabetes Mellitus.

What does exenatide twice daily target?

Exenatide twice daily targets GLP1R, the glucagon-like peptide-1 receptor, and acts as an agonist at this receptor. By activating GLP1R, the drug is designed to support glycemic control in Type 2 Diabetes Mellitus. It is a small molecule developed by AstraZeneca PLC under ticker AZN.

Who makes exenatide twice daily?

Exenatide twice daily is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is responsible for the clinical development of this GLP1R agonist for Type 2 Diabetes Mellitus. The asset is currently in Phase 3 development.

What phase is exenatide twice daily in?

Exenatide twice daily is in Phase 3 clinical development for Type 2 Diabetes Mellitus. It is an investigational GLP1R agonist and is not described as approved. One Phase 3 trial has been completed, and no trials are currently active.

What clinical trials is exenatide twice daily in?

Exenatide twice daily has been studied in the completed Phase 3 trial NCT00434954, titled Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes. The trial enrolled 494 participants in Germany, was randomized, active-controlled, and included adults aged 18 years and older.

Is exenatide twice daily the same as exenatide twice daily (BID)?

Yes. Exenatide twice daily is also known as exenatide twice daily (BID). BID stands for twice daily, referring to the dosing frequency. Both names refer to the same GLP1R agonist developed by AstraZeneca PLC (ticker AZN) for Type 2 Diabetes Mellitus.