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Insuline glulisine

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Sanofi|Last Updated: Oct 16, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment202

FDA Designations

No designations recorded

Clinical trial landscape

Insuline glulisine · 2 trials · 1 indication

Phase 3 2
NCT00545337Glulisine + Lantus in Type I PatientsDiabetes Mellitus, Type 1
COMPLETED60 Analytics
NCT00546702Glulisine + Lantus in Type I PatientsDiabetes Mellitus, Type 1
COMPLETED142 Analytics
PHASE3COMPLETED
Glulisine + Lantus in Type I Patients
Diabetes Mellitus, Type 1
NCT0054533760
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PHASE3COMPLETED
Glulisine + Lantus in Type I Patients
Diabetes Mellitus, Type 1
NCT00546702142
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Study Endpoints

Primary Endpoints

Change of HbA1c
from baseline to endpoint
Change of HbA1c.
from baseline to endpoint.

Secondary Endpoints

Change of HbA1c
from baseline to week 26
Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins
from baseline to endpoint
Change in HbA1c.
from baseline (week 1) to weeks 12 and 26
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Insuline glulisineDRUG -
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Eligibility Criteria

Age Range19 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * type I diabetes mellitus (onset of diabetes under the age of 40), * an HbA1c range of \>6.5 - \<11%, * and on multiple injection regimen (more than 1 year of continuous insulin treatment), * body mass index \<35. Exclusion Criteria: * Active proliferative diabetic retinopath...

Countries:UkraineRussia
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