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BI 10773 low dose

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 30, 2014

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 Enrollment494
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01011868Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 DiabetesPHASE2 COMPLETED 494 — — Nov 1, 2009 -Sep 30, 201499 United States, Denmark +5
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Study Endpoints
Primary Endpoints
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
Baseline and 18 weeks

Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment

Secondary Endpoints
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment
Baseline and 18, 54 and 78 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Baseline, 18, 54 and 78 weeks
Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Baseline, 18, 54 and 78 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BI 10773 low doseEXPERIMENTALPatients receive BI 10773 low dose daily
BI 10773 high doseEXPERIMENTALPatients receive BI 10773 high dose daily
placeboPLACEBO_COMPARATORPatients receive placebo to match BI 10773 daily
Interventions
NameTypeDescription
BI 10773 placeboDRUGBI 10773 placebo
BI 10773 low doseDRUGBI 10773 low dose
BI 10773 high doseDRUGBI 10773 high dose
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites99

Inclusion criteria: 1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation 2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant ...

Countries:United StatesDenmarkFranceIrelandPortugalSouth KoreaUnited Kingdom
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