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B- Exenatide twice daily

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |AstraZeneca PLC|Last 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

Clinical trial landscape

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 used for?

B- Exenatide twice daily is used for the treatment of Type 2 Diabetes Mellitus. It is a small molecule being developed by AstraZeneca PLC for metabolic conditions. The drug is currently in Phase 2 clinical development, with one completed trial evaluating its effect on glucose control in subjects with Type 2 Diabetes Mellitus.

Who makes B- Exenatide twice daily?

B- Exenatide twice daily is being developed by AstraZeneca PLC, a pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is in Phase 2 clinical development for the treatment of Type 2 Diabetes Mellitus, a metabolic condition.

What phase is B- Exenatide twice daily in?

B- Exenatide twice daily is in Phase 2 clinical development. It is an investigational drug for the treatment of Type 2 Diabetes Mellitus, and it has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is B- Exenatide twice daily in?

B- Exenatide twice daily has one completed clinical trial, NCT00085969, titled "Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus." This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 99 participants in the United States and is now completed.

Is B- Exenatide twice daily the same as Exenatide?

B- Exenatide twice daily is a formulation of exenatide, a drug used for Type 2 Diabetes Mellitus. The name indicates the dosing frequency of twice daily. It is being developed by AstraZeneca PLC and is currently in Phase 2 clinical development, with one completed trial.