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NPH insulin

Phase 3

Diabetes Mellitus, Insulin-Dependent | Small molecule | Metabolic |Sanofi|Last Updated: May 20, 2016

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment572
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00115570Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and AdolescentsPHASE3 COMPLETED 572 — — Apr 1, 2005Nov 1, 2006May 20, 20161 United States
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Study Endpoints
Primary Endpoints
Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint
week 26 or last observed treatment
Secondary Endpoints
Change from Baseline in GHb at weeks 12 and 26
weeks 12 and 26
Change from Baseline in Self-monitored glucose parameters
weeks 4, 12, 18, 26, and endpoint;
Incidence of Symptomatic hypoglycemia
first dose of study up to last dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Insulin GlulisineEXPERIMENTALInsulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks
Insulin LisproACTIVE_COMPARATORInsulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks
Interventions
NameTypeDescription
Insulin glulisineDRUGSubcutaneous injection
insulin lisproDRUGSubcutaneous injection
insulin glargineDRUGSubcutaneous injection once daily
NPH insulinDRUGsubcutaneous injection twice daily
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Eligibility Criteria
Age Range4 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Girls/boys, 4-17 years, inclusive; * Girls not yet of childbearing potential or, if sexually active, agree to use reliable medically accepted contraceptive measure during study; * Type 1 diabetes mellitus established in medical history: for example, but not limited to, clear s...

Countries:United States
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