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JNJ-41443532

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Johnson & Johnson|Last Updated: Dec 11, 2013

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment89
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01230749A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes MellitusPHASE2 COMPLETED 89 — — Dec 1, 2010Jun 1, 2011Dec 11, 2013 - —
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Study Endpoints
Primary Endpoints
Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)
From baseline (Day -1) to Day 28

Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.

Secondary Endpoints
Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)
From baseline to Day 28
Change From Baseline to Day 28 in Insulin Secretion
From baseline to Day 28
Change From Baseline to Day 28 in Insulin Resistance
From baseline to Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-41443532 250 mgEXPERIMENTALParticipants will receive JNJ-41443532 250 mg in morning and evening for 28 days.
JNJ-41443532 1000 mgEXPERIMENTALParticipants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days.
PioglitazoneACTIVE_COMPARATORParticipants will receive pioglitazone 30 mg in morning for 28 days.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days.
Interventions
NameTypeDescription
JNJ-41443532DRUGParticipants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.
Pioglitazone 30 mgDRUGParticipants will receive tablet pioglitazone 30 mg orally in morning for 28 days.
PlaceboDRUGParticipants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
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Eligibility Criteria
Age Range25 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening * On a stable treatment regimen for at least 2 months prior screening * Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening ...

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