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Albiglutide or exenatide

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Dec 16, 2016

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment361
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00518115Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin OnlyPHASE2 COMPLETED 361Apr 1, 2007May 1, 2008Dec 16, 2016163 United States, Chile +1
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Study Endpoints
Primary Endpoints
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
Baseline and Week 16

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

Secondary Endpoints
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
Change From Baseline in Waist Circumference at Week 16
Baseline and Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Albiglutide (GSK716155) or exenatideDRUGAlbiglutide weekly subcutaneous injection or exenatide twice daily injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites163

Inclusion Criteria: * Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus \[American Diabetes Association, 2004a\] at least three months pre...

Countries:United StatesChileDominican Republic
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