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exenatide

Phase 3

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,189

FDA Designations

No designations recorded

Clinical trial landscape

exenatide · 1 trial · 1 indication

Phase 3 1
NCT00717457A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.Diabetes Mellitus Type 2
COMPLETED1,189 Analytics
PHASE3COMPLETED
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in HbA1c
24 weeks

Secondary Endpoints

Fasting body weight
24 weeks
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
24 weeks
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
exenatideACTIVE_COMPARATOR -
taspoglutide 10mgEXPERIMENTAL -
taspoglutide 10mg/20mgEXPERIMENTAL -

Interventions

NameTypeDescription
exenatideDRUG5mg twice daily for 4 weeks followed by 10mg twice daily
taspoglutideDRUG10mg once weekly
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites216

Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks; * HbA1c \>=7.0% and \<=10% at screening; * BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at lea...

Countries:United StatesArgentinaAustraliaBrazilCanadaDenmarkFinlandFranceGermanyGreeceGuatemalaIsraelItalyMexicoNew ZealandPeruPuerto RicoRussiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandThailandUkraineUnited Kingdom
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Frequently asked questions about exenatide

What is exenatide used for?

Exenatide is used for the treatment of type 2 diabetes mellitus in patients inadequately controlled with metformin, thiazolidinedione, or a combination of both. It is being studied as an active comparator in a Phase 3 clinical trial.

Who makes exenatide?

Exenatide is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is being evaluated in a Phase 3 clinical trial for type 2 diabetes mellitus.

What phase is exenatide in?

Exenatide is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is exenatide in?

Exenatide was studied in the completed Phase 3 trial NCT00717457, which enrolled 1189 patients with type 2 diabetes mellitus. The trial compared taspoglutide versus exenatide in patients inadequately controlled with metformin, thiazolidinedione, or both.

What does exenatide target?

Exenatide is a small molecule being studied for type 2 diabetes mellitus. The specific molecular target is not disclosed in the available information, so its mechanism of action is not described here.