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Technosphere/Insulin

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |MannKind Corporation|Last Updated: Oct 14, 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00419302To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.PHASE2 COMPLETED 16Oct 1, 2003Apr 1, 2004Oct 14, 20091 Germany
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Study Endpoints
Primary Endpoints
Glycemic response to a meal challenge
Secondary Endpoints
Serum insulin concentrations measured for Technosphere/Insulin administration and subcutaneous insulin administration across 13 time points over a 270 minute period
Safety variables
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Technosphere/InsulinDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Clinical diagnosis of type 2 diabetes mellitus. * Current regimen of intensified insulin therapy for at least 6 months. * Body Mass Index less than 35 kg/m2. * HbA1c less than or equal to 9%. * Non-smoker for at least 2 years. * If medications in addition to insulin are taken ...

Countries:Germany
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