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Remogliflozin etabonate

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |GSK plc|Last Updated: Mar 19, 2012

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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00671424A Study To Compare Effects Of GSK189075 In Combination With Either Furosemide Or HydrochlorothiazidePHASE1 COMPLETED 48Mar 1, 2008May 1, 2008Mar 19, 20121 United States
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Study Endpoints
Primary Endpoints
Serum sodium and potassium concentrations:
baseline, Day 3, and Days 9-15
Secondary Endpoints
adverse events:
each visit
Physical Exam:
screening,Days -1,15,follow-up
ECG & vital signs:
Days -1,3,8,9,14,15,follow-up
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Hydrochlorothiazide (HCTZ)DRUG -
Remogliflozin etabonate (GSK189075)DRUG -
FurosemideDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range...

Countries:United States
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