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Insulin Lispro 6 Day

Phase 3

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

Insulin Lispro 6 Day target and mechanism

Molecular targetINSR
Target classAgonist
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

Insulin Lispro 6 Day clinical trials

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 1Unlock trial analytics

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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Frequently asked questions about Insulin Lispro 6 Day

What is Insulin Lispro 6 Day used for?

Insulin Lispro 6 Day is an investigational insulin therapy being studied for the treatment of type 1 diabetes mellitus. It is designed for use in insulin pumps, where it is compared with insulin aspart in a six-day pump use setting. It is not yet approved for commercial use.

How does Insulin Lispro 6 Day work?

Insulin Lispro 6 Day works as an agonist of the insulin receptor (INSR). By binding to and activating INSR, it mimics the action of endogenous insulin to promote glucose uptake into cells and lower blood glucose levels. This mechanism supports its development for type 1 diabetes management.

Who is developing Insulin Lispro 6 Day?

Insulin Lispro 6 Day is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Eli Lilly is the sponsor responsible for the clinical development of this insulin lispro formulation.

What phase is Insulin Lispro 6 Day in?

Insulin Lispro 6 Day is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA or any other regulatory agency. The Phase 3 trial has been completed, and no active trials are currently listed.

What clinical trials is Insulin Lispro 6 Day in?

Insulin Lispro 6 Day has been evaluated in one completed Phase 3 trial, NCT01134107, titled "Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use." This randomized, double-blind, active-controlled study enrolled 133 participants with type 1 diabetes across France, Germany, and Hungary.

Is Insulin Lispro 6 Day the same as Insulin Lispro 6 Day (6D)?

Yes, Insulin Lispro 6 Day is also known as Insulin Lispro 6 Day (6D). The abbreviation 6D refers to the same investigational insulin lispro formulation developed by Eli Lilly and Company for type 1 diabetes pump therapy.