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Lantus

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Jan 11, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment490
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00046501Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes AdolescentsPHASE3 COMPLETED 250 — — Nov 1, 2002 -Jan 11, 20111 United States
NCT00046462Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other TreatmentPHASE3 COMPLETED 240 — — Nov 1, 2001Dec 1, 2004Jan 11, 20111 United States
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Study Endpoints
Primary Endpoints
to measure change in glycemic control as measured by hemoglobin A1c (A1c).
from baseline to endpoint (last available post-treatment assessment)
To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy
During the Study Conduct
Secondary Endpoints
Change in A1c
from baseline to individual study time points
Percentage of subjects achieving an A1c ≤7.0; percent of preteens (12 years and below) achieving 8%; teens (13-18 years) achieving 7.5%
During the study conduct
Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined
from baseline to endpoint
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Lantus (insulin glargine [rDNA origin] injection)DRUG -
Humulin NDRUG -
Humulin LDRUG -
LisproDRUG -
MetforminDRUG -
GlyburideDRUG -
ThiazolidinedioneDRUG -
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Eligibility Criteria
Age Range9 Years — 17 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Type 1 diabetes treated with insulin only for at least 1 year, * with a Tanner stage of ≥ 2, * had evidence of decreased insulin secretory capacity (fasting C-peptide concentration ≤0.5 mmol/L) and 7.0%≤A1c≤9.5% at screening. The above information is not intended to contain a...

Countries:United States
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