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insulin lispro Low Mix

Phase 4

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Oct 31, 2007

insulin lispro Low Mix development status

Highest phase Phase 4 (NCT00420095)
Phase scored for LLYPhase 3
Registered trials 1 across 1 sponsor since Jan 2007

insulin lispro Low Mix target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as insulin lispro injection [rDNA origin] Low Mix, Insulin lispro mix 25

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment423

FDA Designations

No designations recorded

insulin lispro Low Mix clinical trials

insulin lispro Low Mix · 2 trials · 2 indications

Phase 3 2
NCT00231725Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily InsulinType 2 Diabetes Mellitus
COMPLETED370 Analytics
NCT00551356Lispro Mix 25 vs. Glargine in Type 2 DiabeticsDiabetes Mellitus Type 2
COMPLETED53 Analytics
PHASE3COMPLETED
Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin
Type 2 Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
Lispro Mix 25 vs. Glargine in Type 2 Diabetics
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.
Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
16 weeks or end of study.

Secondary Endpoints

To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia
To assess overall patient perception of the device's performance through a patient questionnaire.
Hemoglobin A1c measured at endpoint
16 weeks or end of study.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
2ACTIVE_COMPARATORInsulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
1ACTIVE_COMPARATORLispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.

Interventions

NameTypeDescription
insulin lispro injection [rDNA origin] Low MixDRUG -
Insulin lispro mix 25DRUGInsulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.
GlargineDRUGInsulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
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Eligibility Criteria

Age Range25 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Type 2 Diabetes * Already on Lilly insulin or beginning insulin therapy * 25 to 75 years old inclusive Exclusion Criteria: * Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's cou...

Countries:United StatesSpainUnited KingdomMexico
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Frequently asked questions about insulin lispro Low Mix

What is insulin lispro Low Mix used for?

Insulin lispro Low Mix is used to treat Diabetes Mellitus Type 2. It is a fixed-ratio insulin product studied in adults with type 2 diabetes, including patients on twice-daily insulin regimens. Eli Lilly and Company is developing it, and the program has reached Phase 3 clinical development.

What does insulin lispro Low Mix target?

Insulin lispro Low Mix targets INSR, the insulin receptor, and acts as an agonist at that receptor. By activating the insulin receptor, the product is designed to support glucose lowering in people with type 2 diabetes. Its target class is receptor agonism, consistent with insulin-based therapy.

Who makes insulin lispro Low Mix?

Eli Lilly and Company makes insulin lispro Low Mix. The company trades under the ticker LLY and is the developer of this fixed-ratio insulin lispro product for Diabetes Mellitus Type 2. The asset is in Phase 3 development.

What phase is insulin lispro Low Mix in?

Insulin lispro Low Mix is in Phase 3 development for Diabetes Mellitus Type 2. It is an investigational product and is not approved. Two Phase 3 trials have been completed, with no active trials currently listed, and total enrollment across those completed studies was 423 participants.

What clinical trials is insulin lispro Low Mix in?

Two completed Phase 3 trials have studied insulin lispro Low Mix. NCT00551356 compared Lispro Mix 25 with glargine in type 2 diabetics in Mexico and enrolled 53 participants. NCT00231725 examined pen-related complaints in type 2 diabetics on twice-daily insulin across the United States, Spain, and the United Kingdom, enrolling 370 participants.

Is insulin lispro Low Mix the same as insulin lispro mix 25?

Yes. Insulin lispro Low Mix is also known as insulin lispro mix 25 and insulin lispro injection [rDNA origin] Low Mix. These names refer to the same fixed-ratio insulin lispro product developed by Eli Lilly and Company for Diabetes Mellitus Type 2. Searches for any of these names point to the same asset.