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Humalog Mix 50

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 31, 2006

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00191581Local Registration Trial in China Humalog Mix 50PHASE3 COMPLETED 120 — — Mar 1, 2005Apr 1, 2006Jul 31, 20062 China
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Study Endpoints
Primary Endpoints
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50
Secondary Endpoints
The secondary objectives of the study are:
Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50.
Assess HbA1c values at baseline and after treatment with human insulin mix 50/50.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Humalog Mix 50DRUG -
Human Insulin Mix 50:50DRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Men and women who have had either type 1 or type 2 diabetes (World Health Organization\[WHO\]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent. 2. Have been treated with commercially available human i...

Countries:China
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