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NC-503

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Aug 24, 2010

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 Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00675857A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II DiabetesPHASE2 COMPLETED 200Apr 1, 2008May 1, 2010Aug 24, 201021 Canada
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Study Endpoints
Primary Endpoints
Change from baseline to Week 26 in HbA1c levels
26 weeks
Secondary Endpoints
Change in HbA1c levels
26 weeks
The rate of achieving glycemic control
26 weeks
Change in fasting serum glucose levels
26 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
APLACEBO_COMPARATOR -
BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
NC-503 (eprodisate disodium)DRUGcapsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
placeboOTHERDosage: 4 capsules BID for 26 weeks
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Eligibility Criteria
Age Range30 Years — 95 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Age and gender eligibility: 30 years and older * Diagnosis of Type 2 diabetes mellitus * Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to t...

Countries:Canada
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