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B- Exenatide twice daily

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: Feb 23, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

B- Exenatide twice daily clinical trials

B- Exenatide twice daily · 1 trial · 1 indication

Phase 2 1
NCT00085969Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2
COMPLETED99 Analytics
PHASE2COMPLETED
Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
Baseline, Day 28

Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)

Secondary Endpoints

Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28
Baseline, Day 14, Day 28
Change in body weight from Baseline to Day 14 and to Day 28
Baseline, Day 14, Day28
Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28
Baseline, Day 14, Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1 - Placebo 0.04 mL twice dailyPLACEBO_COMPARATOR -
A2 - Placebo 0.04 mL once dailyPLACEBO_COMPARATOR -
A3 - Placebo 0.08 mL once dailyPLACEBO_COMPARATOR -
B - Exenatide 10 mcg twice dailyEXPERIMENTAL -
C - Exenatide 10 mcg once dailyEXPERIMENTAL -
D - Exenatide 20 mcg once dailyEXPERIMENTAL -

Interventions

NameTypeDescription
Placebo 0.04 mL twice dailyDRUGSubcutaneously injected, 0.04 mL, twice daily
Placebo 0.04 mL once dailyDRUGSubcutaneously injected, 0.04 mL, once daily
Placebo 0.08 mL once dailyDRUGSubcutaneously injected, 0.08 mL, once daily
B - Exenatide 10 mcg twice dailyDRUGSubcutaneously injected, 10 mcg (0.04 mL), twice daily
C - Exenatide 10 mcg once dailyDRUGSubcutaneously injected, 10 mcg (0.04 mL), once daily
Exenatide 20 mcg once dailyDRUGSubcutaneously injected, 20 mcg (0.08 mL), once daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years. Exclusion Criteria: * Subject has a clinically significant history or presence of any of the following condit...

Countries:United States
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Frequently asked questions about B- Exenatide twice daily

What is B- Exenatide twice daily?

B- Exenatide twice daily is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for the treatment of type 2 diabetes mellitus. It is being studied as monotherapy to assess its effect on glucose control in adults with the condition. The program is in Phase 2 clinical development.

What is B- Exenatide twice daily used for in type 2 diabetes?

B- Exenatide twice daily is being evaluated for glucose control in adults with type 2 diabetes mellitus. A completed Phase 2 trial, NCT00085969, studied it as monotherapy in subjects with the condition, measuring its effect on glycemic control. It is an investigational agent and is not approved for this use.

Who makes B- Exenatide twice daily?

B- Exenatide twice daily is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the drug in type 2 diabetes mellitus.

What phase is B- Exenatide twice daily in?

B- Exenatide twice daily is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved for any indication.

What clinical trials is B- Exenatide twice daily in?

B- Exenatide twice daily has been studied in one completed Phase 2 trial, NCT00085969, titled Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus. The trial enrolled 99 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.