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LY041001

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Dec 21, 2007

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00099515Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)PHASE2 COMPLETED 97 — — Nov 1, 2004Sep 1, 2005Dec 21, 20076 United States, Argentina +2
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Study Endpoints
Primary Endpoints
Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP
4 weeks
Secondary Endpoints
Assess the suitability of the HIIP delivery system for type 2 diabetes patients
4 weeks
Compare the SMBG profiles of preprandial HIIP administration with standard training and with intensive training Assess patient compliance with the HIIP delivery system Directions for Use (DFU) provided by the Sponsor with and without intensive training
4 weeks
Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
Interventions
NameTypeDescription
LY041001 (HIIP)DRUGInhalation, capsule, TID 3 times per day min 6 IU max 60 IU
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Type 2 diabetes for at least 12 months * Age 18 or older. * Taking at least 1 oral antihyperglycemic medication. * Have an HbA1C between 7.5 and 12. * Be a nonsmoker Exclusion Criteria: * Body Mass Index (BMI) greater than 40. * Have frequent episodes of severe hypoglycemia....

Countries:United StatesArgentinaPortugalSouth Africa
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