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ORMD 0801

Phase 2

Brittle Type I Diabetes Mellitus | Small molecule | Metabolic |Oramed Pharmaceuticals Inc.|Last Updated: Aug 11, 2011

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00867594Effectiveness of Oral Insulin in Unstable Type 1 Diabetes PatientsPHASE2 COMPLETED 12 — — Jul 1, 2008Aug 1, 2008Aug 11, 20111 Israel
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Study Endpoints
Primary Endpoints
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
15 days
Secondary Endpoints
To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes
15 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ORMD 0801DRUG1 capsule ORMD 0801 3 times a day, before each meal
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 1 diabetes mellitus * Male or female aged 18-50 years inclusive * Body weight between 50-100kg and BMI between 18 and 30 kg/m2 * Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia * No other medical problems Exclusion Criteria: * Hi...

Countries:Israel
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