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Insulin lispro 2 day reservoir in-use

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 27, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

Clinical trial landscape

Insulin lispro 2 day reservoir in-use · 1 trial · 1 indication

Phase 3 1
NCT01109316Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump UseDiabetes Mellitus, Type 1
COMPLETED132 Analytics
PHASE3COMPLETED
Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Diabetes Mellitus, Type 1
NCT01109316132
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Study Endpoints

Primary Endpoints

Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use
8 weeks of each treatment

Secondary Endpoints

Mean SMBG
8 weeks for each treatment
Mean Daily Insulin Dose (Total, Basal, and Bolus)
8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values
Baseline, 8 weeks for each treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin Lispro 2 DayACTIVE_COMPARATOR -
Insulin Lispro 6 DayEXPERIMENTAL -
Insulin Aspart 6 DayACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Insulin lispro 2 day reservoir in-useDRUGInsulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin lispro 6 day reservoir in-useDRUGInsulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.
Insulin aspart 6 day reservoir in-useDRUGInsulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.
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Eligibility Criteria

Age Range13 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

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

Countries:United States
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