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Actrapid HM

Phase 2

Diabetes, Type I | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Apr 7, 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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00654121Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree RelativesPHASE2 COMPLETED 112Feb 1, 2000Nov 1, 2007Apr 7, 20083 Belgium
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Study Endpoints
Primary Endpoints
Fasting glycemia;
2004
fasting and stimulated plasma C-peptide and proinsulin values;
2004
islet cell autoantibodies;
2004
body weight gain.
2004
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Study Design & Arms
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
2NO_INTERVENTION -
Interventions
NameTypeDescription
Actrapid HMDRUG56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
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Eligibility Criteria
Age Range5 Years — 39 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Sibling/offspring of a Type 1 diabetic patient * in good general condition * age 5-39 years * fasting plasma glucose \<126 mg/dL AND an OGTT that is non-diabetic by 1997 ADA criteria (33): 1. Normal glycemia: * fasting plasma glucose \< 110 mg/dL and * 2 hour pla...

Countries:Belgium
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