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Detemir

Phase 3

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Nov 11, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment442
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00494013Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)PHASE3 COMPLETED 442Aug 1, 2007Sep 1, 2008Nov 11, 200956 United States, Argentina +7
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Study Endpoints
Primary Endpoints
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Baseline, 24 Weeks
Secondary Endpoints
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Baseline, 12 Weeks, 24 Weeks
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
24 Weeks
Glycemic Variability
24 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Insulin Lispro Protamine SuspensionEXPERIMENTALInsulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
DetemirACTIVE_COMPARATORDetemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
Interventions
NameTypeDescription
Insulin Lispro Protamine SuspensionDRUGPatient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
DetemirDRUGPatient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: 1. Have type 2 diabetes mellitus for at least 1 year. 2. Are at least 18 years old. 3. Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the followin...

Countries:United StatesArgentinaHungaryIndiaMexicoPolandSouth KoreaSpainTaiwan
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