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Neutral protamine hagedorn insulin

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 10, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00490854A Study for Patients With Type 2 Diabetes MellitusPHASE2 COMPLETED 129 — — Jul 1, 2007May 1, 2008Jul 10, 200813 Japan
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Study Endpoints
Primary Endpoints
Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase
24, 48 and 76 weeks after Randomization
Secondary Endpoints
8-point SMBG profiles.
24, 48 and 76 weeks after Randomization
Mean change in HbA1c from baseline to the end.
24, 48 and 76 weeks after Randomization
Mean dosage of both preprandial and basal insulin.
24, 48 and 76 weeks after Randomization
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
Interventions
NameTypeDescription
Human Insulin Inhalation PowderDRUGpatient specific, inhaled, at meals, 76 weeks
Neutral protamine hagedorn insulinDRUGpatient specific dose, injected, daily, 76 weeks
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Type 2 diabetes mellitus for at least 6 months 2. One or more oral antihyperglycemic medications for at least 12 weeks 3. HbA1c equal to or greater than 7.0%, and equal to or less than 10.5% 4. Nonsmokers, have not smoked for at least 6 months and agree not to smoke (cigars, ...

Countries:Japan
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