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nexium

Phase 3

Type 2 Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 3, 2012

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00699426The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 DiabetesPHASE3 COMPLETED 41Jun 1, 2008Jun 1, 2009Sep 3, 2012 -
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Study Endpoints
Primary Endpoints
insulin secretion
1 year
Secondary Endpoints
blood pressure
1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nexium + YoghurtACTIVE_COMPARATOR -
Nexium + PlaceboPLACEBO_COMPARATOR -
Placebo+ YoghurtPLACEBO_COMPARATOR -
placebo+placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
nexiumDRUG40 mg once daily is tested together with Yoghurt
YoghurtDIETARY_SUPPLEMENTYoghurt
placebo+placeboDRUGplacebo and placebo are tested.
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Eligibility Criteria
Age Range40 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Type 2 diabetes (WHO criteria) treated with metformin and/or sulfonylureas or diet * Males and females between 40 and 70 years * HbA1c between 6,0-10,0 * Diabetes duration \> 1 year Exclusion Criteria: * Kidney disease (s-creatinine above the upper limit of normal range). * ...

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