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E1 and G1

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Opko Health Inc.|Last Updated: Oct 18, 2019

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00239187A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1PHASE1 COMPLETED 30Sep 1, 2005Jan 1, 2007Oct 18, 20193 United States
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
Secondary Endpoints
To evaluate the pharmacokinetics (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
E1 and G1DRUG -
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Eligibility Criteria
Age Range30 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Informed consent obtained from participants * Clinical diagnosis Type 2 diabetes requiring treatment with Metformin and/or TZD and who are otherwise healthy * On a stable Metformin and/or TZD regimen for at least 60 days prior to screening * Maximum stimulated c-peptide level ...

Countries:United States
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