Recent Updates
Recently added Catalysts

Insulin Lispro Protamine

Phase 3

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

Target and mechanism

ModalitySmall molecule

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment442

FDA Designations

No designations recorded

Clinical trial landscape

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 2
NCT00560417339
Unlock trial analytics
PHASE3COMPLETED
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
Diabetes Mellitus Type 2
NCT00494013442
Unlock trial analytics
PHASE3COMPLETED
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)
Diabetes Mellitus, Type 2
NCT00510952471
Unlock trial analytics
PHASE3COMPLETED
Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1
NCT00487240387
Unlock 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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria