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ISIS-PTP1BRx

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Mar 3, 2015

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 Enrollment92
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01918865Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 DiabetesPHASE2 COMPLETED 92 — — Aug 1, 2013Feb 1, 2015Mar 3, 201521 Argentina, Canada +1
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Study Endpoints
Primary Endpoints
Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
38 weeks
Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
27 weeks
Secondary Endpoints
Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy
27 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ISIS-PTP1BRxEXPERIMENTALWeekly Dosing for 26 Weeks
PlaceboPLACEBO_COMPARATORWeekly Dosing for 26 Weeks
Interventions
NameTypeDescription
ISIS-PTP1BRxDRUG -
PlaceboDRUG -
daily OAD (metformin and/or sulfonylurea)DRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Body mass index (BMI) \>/= 27 kg/m2 * HbA1c between 7.5% and 10.5% (inclusive) * C-Peptide (fasting) greater than or equal to 500 pmol/L * On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for \>/= 3 months prior to screening, and remain on...

Countries:ArgentinaCanadaSouth Africa
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