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Insulin Lispro Protamine

Phase 3

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Jan 13, 2011

Insulin Lispro Protamine target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as Insulin Lispro Protamine Suspension, Insulin Lispro Protamine Suspension (ILPS)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment1,639

FDA Designations

No designations recorded

Insulin Lispro Protamine clinical trials

Insulin Lispro Protamine · 4 trials · 3 indications

Phase 3 4
NCT00560417Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and ExenatideDiabetes Mellitus, Type 2
COMPLETED339 Analytics
NCT00494013Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)Diabetes Mellitus Type 2
COMPLETED442 Analytics
NCT00510952Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)Diabetes Mellitus, Type 2
COMPLETED471 Analytics
NCT00487240Comparison of Two Basal Insulin Therapies for Patients With Type 1 DiabetesDiabetes Mellitus, Type 1
COMPLETED387 Analytics
PHASE3COMPLETED
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
Diabetes Mellitus Type 2Unlock trial analytics
PHASE3COMPLETED
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Baseline, Endpoint (LOCF) up to 24 weeks

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.

Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Baseline, 24 Weeks
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
baseline and 32 weeks

Secondary Endpoints

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
24 weeks, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ILPSACTIVE_COMPARATORInsulin Lispro Protamine Suspension (ILPS)
GlargineACTIVE_COMPARATORInsulin Glargine
Insulin Lispro Protamine SuspensionEXPERIMENTALInsulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
DetemirACTIVE_COMPARATORDetemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
LisproEXPERIMENTALInsulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks

Interventions

NameTypeDescription
Insulin Lispro Protamine SuspensionDRUGAdministered subcutaneously once a day at bedtime
Insulin GlargineDRUGAdministered subcutaneously once a day at bedtime
DetemirDRUGPatient specific dose administered subcutaneously once or twice daily x 24 weeks.
Insulin LevemirDRUGPatient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Must have type 2 diabetes * Must be at least 18 years of age and less than 75 years of age * Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months * Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metfor...

Countries:United StatesPuerto RicoArgentinaHungaryIndiaMexicoPolandSouth KoreaSpainTaiwanBrazilCanadaAustraliaGreeceRomaniaRussia
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Frequently asked questions about Insulin Lispro Protamine

What is Insulin Lispro Protamine?

Insulin Lispro Protamine is an investigational basal insulin developed by Eli Lilly and Company for the treatment of type 1 and type 2 diabetes mellitus. It is a protamine suspension form of insulin lispro designed to provide longer-acting insulin coverage. It is also known as Insulin Lispro Protamine Suspension, or ILPS.

What is Insulin Lispro Protamine used for?

Insulin Lispro Protamine is being studied for glycemic control in adults with type 2 diabetes mellitus and type 1 diabetes mellitus. The clinical program has evaluated it as a basal insulin in patients already taking anti-hyperglycemic medications, including oral diabetes medicines and exenatide.

What does Insulin Lispro Protamine target?

Insulin Lispro Protamine targets INSR, the insulin receptor, and acts as an agonist. By activating the insulin receptor, it supports glucose uptake and lowers blood glucose, which is the basis for its use as a basal insulin in diabetes management.

Who makes Insulin Lispro Protamine?

Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is the developer of Insulin Lispro Protamine. The company has sponsored the clinical trial program evaluating this basal insulin in patients with type 1 and type 2 diabetes.

What phase is Insulin Lispro Protamine in?

Insulin Lispro Protamine is in Phase 3 development. It is investigational and has not been approved by the FDA. Three completed Phase 3 trials have enrolled a total of 1,252 participants, and no active trials are currently listed for this asset.

What clinical trials is Insulin Lispro Protamine in?

The Phase 3 program includes NCT00560417, NCT00510952, and NCT00494013 in type 2 diabetes, plus NCT00487240 in type 1 diabetes. All four trials are completed, were randomized and active-controlled, and enrolled adults aged 18 years and older across multiple countries.

Is Insulin Lispro Protamine the same as Insulin Lispro Protamine Suspension?

Yes. Insulin Lispro Protamine is also known as Insulin Lispro Protamine Suspension, abbreviated ILPS. These names refer to the same Eli Lilly basal insulin product candidate, so searches using either name point to the same investigational asset.