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Tesaglitazar

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |AstraZeneca PLC|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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00280865GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 DiabetesPHASE2 COMPLETED 500Apr 1, 2002Jun 1, 2003Jul 31, 2006110 United States, Canada +2
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Study Endpoints
Primary Endpoints
Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
Secondary Endpoints
Changes in the following variables from baseline to the end of the randomized treatment period:
The change in plasma glucose and insulin during an oral glucose tolerance test
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
TesaglitazarDRUG -
PioglitazoneDRUG -
Dietary and Lifestyle Modification CounselingBEHAVIORAL -
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Eligibility Criteria
Age Range30 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites110

Inclusion Criteria: * Provision of a written informed consent * Men or women who are 30 to 80 years of age * Female patients: postmenopausal or surgically sterile * Diagnosed with type 2 diabetes with C-peptide levels \> 0.8 ng/mL * Treated with diet alone or treatment with a single oral antidiabet...

Countries:United StatesCanadaFranceMexico
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