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Injectable Insulin

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 9, 2018

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
RandomizedCONTROLLEDBiomarker
Total Trials3
Total Enrollment949
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00356109Evaluate the Efficacy of Insulin Patients With Type 1 DiabetesPHASE3 COMPLETED 494 — — Aug 1, 2006May 1, 2008Mar 9, 201837 United States, Argentina +7
NCT00127634Study of Human Insulin Inhalation Powder in Patients With Type 1 DiabetesPHASE3 COMPLETED 385 — — Jul 1, 2005May 1, 2008Mar 9, 201861 United States, Belgium +4
NCT00447213A Study for Patients With Type 1 Diabetes MellitusPHASE2 COMPLETED 70 — — Apr 1, 2007May 1, 2008Oct 13, 20105 Japan, Taiwan
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Study Endpoints
Primary Endpoints
To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.
6 months
To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.
24 months
Change in HbA1c from baseline
12 and 24 weeks
Secondary Endpoints
Insulin dose requirements
throughout the study
Insulin antibody binding levels
baseline, 1 month, 6 months, follow-up
To compare HbAlc change
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Human Insulin Inhalation PowderDRUGpatient specific dose, inhaled, before meals, 6 months
Injectable insulinDRUGpatient specific dose, injected, before meals, 6 months
Insulin GlargineDRUGpatient specific dose, injectable, before meals, 6 months
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Type 1 diabetes for at least 24 months * Have an HbA1c less than or equal to 11% * Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months * Non-smoker Exclusion Criteria: * Require a daily total insulin dosage greater tha...

Countries:United StatesArgentinaBelgiumFranceGermanyIndiaItalyMexicoPuerto RicoCanadaCroatiaHungaryJapanTaiwan
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