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DA-1229

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Nov 27, 2013

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01941199Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male SubjectsPHASE1 COMPLETED 36Jul 1, 2013 -Nov 27, 20131 South Korea
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Study Endpoints
Primary Endpoints
AUCτ,ss of DA-1229 and metformin
up to 168h
Cmax,ss of DA-1229 and metformin
up to 168h
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
D → M → D+MEXPERIMENTALD : DA-1229 5mg qd, M : metformin 1000mg bid
D → D+M → MEXPERIMENTALD : DA-1229 5mg qd, M : metformin 1000mg bid
M → D → D+MEXPERIMENTALD : DA-1229 5mg qd, M : metformin 1000mg bid
M → D+M → DEXPERIMENTALD : DA-1229 5mg qd, M : metformin 1000mg bid
D+M → M → DEXPERIMENTALD : DA-1229 5mg qd, M : metformin 1000mg bid
D+M → D → MEXPERIMENTALD : DA-1229 5mg qd, M : metformin 1000mg bid
Interventions
NameTypeDescription
DA-1229DRUG -
metforminDRUG -
DA-1229 + metforminDRUG -
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age between 20 to 45, healthy male subjects(at screening) * Body weight between 55kg - 90kg, BMI between 18.0 - 27.0 * FPG 70-125mg/dL glucose level(at screening) * Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed ...

Countries:South Korea
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