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insulin lispro Low Mix

Phase 3

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

Target and mechanism

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 Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

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 Mellitus
NCT00231725370
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PHASE3COMPLETED
Lispro Mix 25 vs. Glargine in Type 2 Diabetics
Diabetes Mellitus Type 2
NCT0055135653
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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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