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ISIS-GCGRRx - Dose Level 1

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Jul 4, 2016

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical trial landscape

ISIS-GCGRRx - Dose Level 1 · 1 trial · 1 indication

Phase 2 1
NCT01885260Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED77 Analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics
Study Endpoints
Primary Endpoints
The effect of ISIS-GCGRRx on serum fructosamine
14 Weeks

Change from Baseline to Week 14

Secondary Endpoints
The safety of ISIS-GCGRRx
25 Weeks
The tolerability of ISIS-GCGRRx
25 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ISIS-GCGRRx Dose Level 1EXPERIMENTALISIS-GCGRRx Dose Level 1
ISIS-GCGRRx Dose Level 2EXPERIMENTALISIS-GCGRRx Dose Level 2
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
ISIS-GCGRRx - Dose Level 1DRUG3 doses on alternate days during the first week and then once weekly for 12 weeks
ISIS-GCGRRx - Dose Level 2DRUG3 doses on alternate days during the first week and then once weekly for 12 weeks
PlaceboDRUG3 doses on alternate days during the first week and then once weekly for 12 weeks
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites24

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:United StatesSouth Africa
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