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Insulin Lispro 6 Day

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Apr 11, 2013

Target and mechanism

ModalitySmall molecule

Also known as Insulin Lispro 6 Day (6D)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment133

FDA Designations

No designations recorded

Clinical trial landscape

Insulin Lispro 6 Day · 1 trial · 1 indication

Phase 3 1
NCT01134107Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump UseDiabetes Mellitus, Type 1
COMPLETED133 Analytics
PHASE3COMPLETED
Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Diabetes Mellitus, Type 1
NCT01134107133
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Study Endpoints

Primary Endpoints

Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use
Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)

Secondary Endpoints

Mean SMBG
Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Days 1-6 for each reservoir cycle throughout each 12-week treatment period
Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
Baseline, endpoint for each 12-week treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin Lispro 6 Day (6D)EXPERIMENTAL -
Insulin Aspart 6 Day (6D)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Insulin Lispro 6 Day (6D)DRUGAdministered by infusion pump for 12 week treatment period
Insulin Aspart 6 Day (6D)DRUGAdministered by infusion pump for 12 week treatment period
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Eligibility Criteria

Age Range13 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months * Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months * Mean total daily insulin dose for 3 days prior to screening less than or equal to 46 un...

Countries:FranceGermanyHungary
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