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Exenatide LAR

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Feb 24, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00103935Study Examining Exenatide Long-Acting Release in Subjects With Type 2 DiabetesPHASE2 COMPLETED 45 — — Feb 1, 2005Oct 1, 2005Feb 24, 20157 United States
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Study Endpoints
Primary Endpoints
Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)
Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours
Secondary Endpoints
Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus
Various time intervals from Day 1 to Week 15
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group A1PLACEBO_COMPARATORPlacebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
Group A2PLACEBO_COMPARATORPlacebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
Group BEXPERIMENTALExenatide lead-in followed by exenatide LAR 0.8 mg weekly
Group CEXPERIMENTALExenatide lead-in followed by exenatide LAR 2.0 mg weekly
Interventions
NameTypeDescription
placeboDRUGSubcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
Exenatide LARDRUGSubcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Has type 2 diabetes treated with either: \*A stable regimen of metformin for a minimum of 3 months, and/or \*Diet modification and exercise for a minimum of 3 months. * Has HbA1c of 7.1% to 11.0%, inclusive. * Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. Ex...

Countries:United States
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