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Lispro

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Sep 15, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment485
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00467376Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes MellitusPHASE3 COMPLETED 485 — — Jan 1, 2007 -Sep 15, 20091 China
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Study Endpoints
Primary Endpoints
Hypoglycemic episodes
From the beginning to end of the study
Change in HbA1c
From baseline to endpoint
Adverse events
From the beginning to the end of study
Secondary Endpoints
Change in HbA1c
From baseline to weeks 12
blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.
from baseline to week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAdministration of Insulin Glulisine
2ACTIVE_COMPARATORAdministration of Lispro
Interventions
NameTypeDescription
Insulin GlulisineDRUG3 times a day before each meal
LisproDRUG3 times a day before each meal
Insulin GlargineDRUGonce daily
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 1 or type 2 diabetic patients * Measure HbA1c 6.5% to 11.0% at visit 1 * More than 3 months of continuous insulin treatment immediately prior to study entry Exclusion Criteria: * Pregnant women The above information is not intended to contain all considerations relevan...

Countries:China
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