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NPH human insulin

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Sanofi|Last Updated: Apr 20, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment764
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00653341Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)PHASE3 COMPLETED 764Jan 1, 2000Oct 1, 2001Apr 20, 20092 United States, Canada
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Study Endpoints
Primary Endpoints
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
Secondary Endpoints
Safety data (Adverse events, vital signs, laboratory values, etc.)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
insulin glargineDRUG -
NPH human insulinDRUG -
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Eligibility Criteria
Age Range30 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents * Body mass index between 26 and 40 kg/m2 * HbA1c between 7.5% and 10.0% * Fasting plasma glucose \>7.8 mmol/L and fasting C-peptide \> or =0.25 nmol/L

Countries:United StatesCanada
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