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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment194

FDA Designations

No designations recorded

Clinical trial landscape

ISIS 113715 · 3 trials · 1 indication

Phase 2 2Phase 1 1
NCT00455598Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With SulfonylureaType 2 Diabetes Mellitus
COMPLETED88 Analytics
NCT00330330Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior TreatmentType 2 Diabetes Mellitus
COMPLETED96 Analytics
PHASE2COMPLETED
Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
Type 2 Diabetes MellitusUnlock trial analytics
PHASE2COMPLETED
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment
Type 2 Diabetes MellitusUnlock trial analytics

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 to 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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Frequently asked questions about ISIS 113715

What is ISIS 113715 used for?

ISIS 113715 is an investigational drug being developed for the treatment of Type 2 Diabetes Mellitus. It is a small molecule being studied in clinical trials to evaluate its safety, tolerability, and activity in people with this condition. The drug is administered by subcutaneous injection and is currently in Phase 2 clinical development.

Who makes ISIS 113715?

ISIS 113715 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus.

What phase is ISIS 113715 in?

ISIS 113715 is in Phase 2 clinical development. It has completed three clinical trials, including two Phase 2 studies and one Phase 1 study. The drug is investigational and has not been approved by regulatory authorities. It remains in clinical development for the treatment of Type 2 Diabetes Mellitus.

What clinical trials is ISIS 113715 in?

ISIS 113715 has completed three clinical trials. NCT00330330 was a Phase 2 study in treatment-naive patients with Type 2 Diabetes Mellitus. NCT00365781 was a Phase 1 dermatologic effects study in healthy volunteers. NCT00455598 was a Phase 2 dose escalation study in patients treated with sulfonylurea. All trials are completed.

Is ISIS 113715 the same as another drug?

ISIS 113715 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being studied under this name in clinical trials for Type 2 Diabetes Mellitus.