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LY2189102

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00942188A Study of LY2189102 in Patients With Type 2 DiabetesPHASE2 COMPLETED 106Jun 1, 2009Nov 1, 2010Sep 18, 201918 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks
Baseline, 12 weeks

Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.

Secondary Endpoints
Change From Baseline in Fasting Glucose at 12 Weeks
Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks
Baseline, 12 weeks
Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks
Baseline, 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
0.6 milligrams (mg) LY2189102EXPERIMENTAL -
18 mg LY2189102EXPERIMENTAL -
180 mg LY2189102EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR0.9% Sodium Chloride
Interventions
NameTypeDescription
LY2189102DRUGParticipants received 2 subcutaneous (SC) injections weekly for 12 weeks.
PlaceboDRUGParticipants received 2 SC injections weekly for 12 weeks.
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Eligibility Criteria
Age Range20 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter \[ng/ml\]), with duration of more than 3 months. * Body mass index between 25 and 40 kilograms per square meter (kg/m2). * Stable on diet and exercise alone, wi...

Countries:United States
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