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ISIS 113715

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Aug 28, 2009

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 Trials3
Total Enrollment194
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00455598Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With SulfonylureaPHASE2 COMPLETED 88 — — Feb 1, 2007May 1, 2009Aug 28, 200939 Poland, Romania +1
NCT00330330Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior TreatmentPHASE2 COMPLETED 96 — — Feb 1, 2003Aug 1, 2006Feb 6, 200810 Poland, Russia
NCT00365781Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715PHASE1 COMPLETED 10 — — Aug 1, 2006Sep 1, 2006Oct 17, 20071 United States
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Study Endpoints
Primary Endpoints
Change and % change from baseline HbA1c
13 weeks
Change and % change from baseline fasting glucose (serum and plasma)
13 weeks
Change and % change from baseline seven point glucose profile
13 weeks
Change and % change from baseline mean fasting and insulin c-peptide
13 weeks
Change and % change from baseline fasting proinsulin
13 weeks
Change and % change from baseline proinsulin / insulin ration
13 weeks
Change and % change from baseline lipid and lipoprotein values: TC, LDL, HDL, TG, VLDL, apoB-100
13 weeks
Change and % change from baseline Adiponectin
13 weeks
To evaluate the safety and tolerability of ISIS 113715
To evaluate the pharmacokinetic profile of ISIS 113715
To evaluate the pharmacologic activity of ISIS 113715
Compare the dermatologic responses to 200 mg/1.0 mL and 200 mg/2.0 mL ISIS 113715 administered subcutaneously into separate abdominal sites, with both injections given on the same day.
Evaluate and examine the effect of treatment on laboratory results, vital signs, and adverse events.
Secondary Endpoints
Adverse Events
13 weeks
Clinical laboratory tests
13 weeks
12 lead ECG
13 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
APLACEBO_COMPARATORSulfonylurea + 100 mg/week ISIS 113715 or placebo
BPLACEBO_COMPARATORSulfonylurea + 200 mg/week ISIS 113715 or placebo
Interventions
NameTypeDescription
ISIS 113715DRUGdoses of 100 and 200 mg per week
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Type 2 diabetes mellitus of less than or equal to eight years in duration, diagnosed according to American Diabetes Association criteria * Fasting serum glucose from 150 to 270 mg/dL at screening visit * HbA1c from 7.5 to 11.0 at screening * Being treated with at least 10 mg/d...

Countries:PolandRomaniaRussiaUnited States
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