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Lispro

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Sep 15, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment485

FDA Designations

No designations recorded

Clinical trial landscape

Lispro · 1 trial · 1 indication

Phase 3 1
NCT00467376Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes MellitusDiabetes Mellitus
COMPLETED485 Analytics
PHASE3COMPLETED
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
Diabetes Mellitus
NCT00467376485
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Study Endpoints

Primary Endpoints

Hypoglycemic episodes
From the beginning to end of the study
Change in HbA1c
From baseline to endpoint
Adverse events
From the beginning to the end of study

Secondary Endpoints

Change in HbA1c
From baseline to weeks 12
blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.
from baseline to week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAdministration of Insulin Glulisine
2ACTIVE_COMPARATORAdministration of Lispro

Interventions

NameTypeDescription
Insulin GlulisineDRUG3 times a day before each meal
LisproDRUG3 times a day before each meal
Insulin GlargineDRUGonce daily
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 1 or type 2 diabetic patients * Measure HbA1c 6.5% to 11.0% at visit 1 * More than 3 months of continuous insulin treatment immediately prior to study entry Exclusion Criteria: * Pregnant women The above information is not intended to contain all considerations relevan...

Countries:China
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Frequently asked questions about Lispro

What is Lispro used for?

Lispro is an investigational small molecule being developed for the treatment of Diabetes Mellitus. It is currently in Phase 3 clinical development. The drug is being studied in patients with type 1 or type 2 diabetes mellitus.

Who makes Lispro?

Lispro is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of Lispro in patients with diabetes mellitus.

What phase is Lispro in?

Lispro is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 clinical trial has been completed, involving 485 participants with diabetes mellitus.

What clinical trials is Lispro in?

Lispro has one completed Phase 3 clinical trial registered under NCT00467376, titled 'Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus'. This trial enrolled 485 participants in China and was active-controlled, meaning it compared Lispro against other insulin treatments.

Is Lispro the same as insulin lispro?

Lispro is being studied in a clinical trial that compares it with insulin lispro, insulin glulisine, and insulin glargine. The trial is designed to evaluate these treatments in patients with type 1 or type 2 diabetes mellitus. The drug is an investigational small molecule.