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Insulin lispro 2 day reservoir in-use

Phase 3

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

Insulin lispro 2 day reservoir in-use development status

Highest phase Phase 3
Registered trials 11 across 6 sponsors since Jun 2008

Insulin lispro 2 day reservoir in-use target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as LY275585, Humalog

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

Insulin lispro 2 day reservoir in-use clinical trials

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 1Unlock trial analytics

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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Frequently asked questions about Insulin lispro 2 day reservoir in-use

What is insulin lispro 2 day reservoir in-use?

Insulin lispro 2 day reservoir in-use refers to a rapid-acting insulin lispro formulation evaluated for use in insulin pumps with a reservoir changed every two days. It is being developed by Eli Lilly and Company for type 1 diabetes mellitus. The formulation is designed to provide mealtime and continuous subcutaneous insulin delivery in pump therapy.

What is insulin lispro 2 day reservoir in-use used for in type 1 diabetes?

Insulin lispro 2 day reservoir in-use is used for glycemic control in people with type 1 diabetes mellitus who use insulin pumps. It delivers rapid-acting insulin through a pump reservoir intended for two-day use. The Phase 3 trial enrolled 132 participants aged 13 years and older with type 1 diabetes.

What does insulin lispro 2 day reservoir in-use target?

Insulin lispro 2 day reservoir in-use targets the insulin receptor, INSR, as an agonist. Binding to INSR activates downstream signaling that promotes glucose uptake into muscle and fat tissue and suppresses hepatic glucose output. This receptor-mediated action underlies its glucose-lowering effect in type 1 diabetes.

Who makes insulin lispro 2 day reservoir in-use?

Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is the developer of insulin lispro 2 day reservoir in-use. Lilly is the manufacturer of the insulin lispro molecule and conducted the clinical development program for this pump-use formulation in type 1 diabetes.

What phase is insulin lispro 2 day reservoir in-use in?

Insulin lispro 2 day reservoir in-use has been studied in Phase 3 clinical development. It is an investigational product and is not described as FDA approved. One Phase 3 trial has been completed, and no trials are currently listed as active for this formulation.

What clinical trials is insulin lispro 2 day reservoir in-use in?

The Phase 3 trial NCT01109316, titled Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use, evaluated insulin lispro 2 day reservoir in-use in type 1 diabetes. The completed study enrolled 132 participants in the United States, used an active-controlled design, and included participants aged 13 years and older.