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Glargine insulin

Phase 3

Cystic Fibrosis Related Diabetes | Small molecule | Metabolic |Sanofi|Last Updated: Sep 22, 2005

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00222521Insulin Glargine Vs Standard Insulin TherapyPHASE3 COMPLETED 20Apr 1, 2003Aug 1, 2005Sep 22, 20051 United States
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Study Endpoints
Primary Endpoints
Hemoglobin A1c
Secondary Endpoints
BMI
Body composition by DEXA Scan
# Episodes of illness
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Glargine insulinDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

1. Inclusion Criteria 1. CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl) 1. . The diagnosis must be made at a time when the patient is in his/her basal state of health with no evidence of acute exacerbation in the preceding two months. a). Acute exacerbation ...

Countries:United States
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