Recent Updates
Recently added Catalysts

GSK1614235

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Jun 8, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00976261A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 DiabetesPHASE1 COMPLETED 72Oct 17, 2009Sep 5, 2010Jun 8, 20179 United States, France +2
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Part A: Safety, tolerability parameters: adverse events, gastro-intestinal side effects, subject reported outcomes, clinical laboratory results, ECGs and vital signs
6 days
Part B: Safety, tolerability parameters: adverse events, gastro-intestinal side effects, subject reported outcomes, clinical laboratory results, ECGs and vital signs
1 day
Secondary Endpoints
Part A: Pharmacokinetics
6 days
Part A: Pharmacodynamics
6 days
Part B: Pharmacokinetics
1 day
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK1614235EXPERIMENTALGlucose lowering agent under investigation.
SitagliptinACTIVE_COMPARATORGlucose lowering comparator
PlaceboPLACEBO_COMPARATORPlacebo to match GSK1614235 and placebo to match Sitagliptin
Interventions
NameTypeDescription
GSK1614235DRUGGlucose lowering in Type 2 Diabetes Mellitus
SitagliptinDRUGGlucose lowering in Type 2 Diabetes Mellitus
PlaceboOTHERComparator
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria Part A: * Subjects with documented type 2 diabetes mellitus diagnosis whose HbA1c levels are \>7 and at or less than 9.5%; at screening, who are either controlled by diet alone, or are on monotherapy with oral sulfonylureas, DPP-IV inhibitors (e.g. sitagliptin), or metformin. * M...

Countries:United StatesFranceGermanyUnited Kingdom
Unlock Eligibility Criteria