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SLV337

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Abbott Laboratories|Last Updated: Jan 4, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00924534A Safety PK/PD Study of SLV337 in Patients With Type 2 DiabetesPHASE2 COMPLETED 61 — — Dec 1, 2009Dec 1, 2010Jan 4, 201212 Bulgaria, Poland +1
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Study Endpoints
Primary Endpoints
Change from Baseline in alanine amino transferase level to Day 35
35 days
Change from baseline in Creatinine level to Day 35
35 days
Change from baseline in the count of Red blood cells to Day 35
35 days
Change from baseline in White blood cells count to Day 35
35 days
Change from baseline in Creatinine kinase level to Day 35
35 days
Secondary Endpoints
Change from baseline in Fasting plasma glucose level to Day 28
28 days
Change from baseline in Adiponectin level to Day 28
28 days
Change from baseline in Triglycerides level to Day 28
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboDRUGPlacebo
SLV337DRUGSLV337 400 mg/day
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c \>= 7%, but \< 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) \>40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT \> 1.5 times UNL, creatinine clearance \<60 mL/min

Countries:BulgariaPolandSouth Africa
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Competitive Landscape -Type 2 Diabetes 151 trials
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