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injected insulin

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 17, 2019

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 Enrollment299
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00157339Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPDPHASE3 COMPLETED 299 — — Aug 1, 2005May 1, 2008Sep 17, 2019101 United States, Argentina +14
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Study Endpoints
Primary Endpoints
To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.
12 months
Secondary Endpoints
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.
12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC
12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.
12 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, 12 months
injected insulinDRUGpatient specific dose, injected, before meals, 12 months.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites101

Inclusion Criteria: * Type 1 or type 2 diabetes * asthma or COPD Exclusion Criteria: * Current smoking habit

Countries:United StatesArgentinaBulgariaCanadaChileColombiaCroatiaHong KongHungaryIndiaMexicoPhilippinesPuerto RicoSingaporeTaiwanThailand
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