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SP2086

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Oct 25, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01969357A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 DiabetesPHASE2 COMPLETED 200 — — Jun 1, 2011Jun 1, 2012Oct 25, 20131 China
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Study Endpoints
Primary Endpoints
the change from baseline in HbA1c at 12 week
baseline, week 12
Secondary Endpoints
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
week 12
Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12
Baseline, Week 4, 8, 12
Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12
baseline, week 4 ,12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
50 mg SP2086EXPERIMENTAL -
100 mg SP2086EXPERIMENTAL -
200 mg SP2086EXPERIMENTAL -
100 mg SitagliptinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PlaceboDRUGTablets(n=4),once daily for 84 days
50 mg SP2086DRUGTablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days
100 mg SP2086DRUGTablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days
200 mg SP2086DRUGTablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days
100 mg SitagliptinDRUGTablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days
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Eligibility Criteria
Age Range20 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 20 Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus * Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5% * BMI 19\~35 kg/m2 Exclusion Criteria: * Patient has history of...

Countries:China
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Competitive Landscape -Type 2 Diabetes 151 trials
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