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Exubera

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Feb 8, 2008

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 Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00246623US Inhaled Insulin Dose Titration StudyPHASE3 COMPLETED 120Nov 1, 2005Mar 1, 2007Feb 8, 200816 United States
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Study Endpoints
Primary Endpoints
Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.
Secondary Endpoints
Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Exubera (inhaled insulin)DRUG -
8-point glucose diary (to assess pre- and post prandial glucoses)PROCEDURE -
Meal Tolerance TestPROCEDURE -
24-hour continuous glucose monitoring (at select sites)PROCEDURE -
Pulmonary Function TestingPROCEDURE -
Hypoglycemic Event MonitoringPROCEDURE -
Laboratory AssessmentsPROCEDURE -
Nutritional Counseling and Diabetes EducationBEHAVIORAL -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Male and female, age \>= 18 years and \<= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10% * Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones) E...

Countries:United States
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