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ISIS-GCCRRx

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: May 13, 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 Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01968265Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 DiabetesPHASE2 COMPLETED 38Oct 1, 2013May 1, 2015May 13, 201514 Canada, Romania +1
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Study Endpoints
Primary Endpoints
The effect of ISIS-GCCRRx on serum fructosamine
7 Weeks

Change from Baseline to Week 7

Secondary Endpoints
The safety of ISIS-GCCRRx
18 Weeks
The tolerability of ISIS-GCCRRx
18 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
ISIS-GCCRRxACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ISIS-GCCRRxDRUG3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
PlaceboDRUG3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Male or female, age 18 to 75 * BMI greater than or equal to 25 * HbA1c greater than or equal to 7.5% and less than or equal to 10.5% * Type 2 Diabetes Mellitus and on stable dose of oral metformin * Agree to conduct home-based (fasted) blood glucose testing as directed Exclus...

Countries:CanadaRomaniaSouth Africa
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