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Insuline glulisine

Phase 3

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

Insuline glulisine development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Oct 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment202

FDA Designations

No designations recorded

Insuline glulisine clinical trials

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 1Unlock trial analytics
PHASE3COMPLETED
Glulisine + Lantus in Type I Patients
Diabetes Mellitus, Type 1Unlock trial analytics

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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Frequently asked questions about Insuline glulisine

What is insuline glulisine used for?

Insuline glulisine is used to treat Diabetes Mellitus, Type 1. It is a rapid-acting insulin therapy studied in combination with Lantus (insulin glargine) in adult patients with type 1 diabetes. Sanofi is the developer of this asset.

Who makes insuline glulisine?

Insuline glulisine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor behind the clinical development program for this rapid-acting insulin analog in type 1 diabetes.

What phase is insuline glulisine in?

Insuline glulisine is in Phase 3 clinical development for Diabetes Mellitus, Type 1. The program includes two completed Phase 3 trials with a combined enrollment of 202 patients. No active trials are currently listed for this asset.

What clinical trials is insuline glulisine in?

Insuline glulisine has been studied in two completed Phase 3 trials. NCT00546702, titled Glulisine + Lantus in Type I Patients, enrolled 142 patients in Russia. NCT00545337, with the same title, enrolled 60 patients in Ukraine. Both trials required participants to be at least 18 years old.

How was insuline glulisine studied in its clinical trials?

Both Phase 3 trials evaluated insuline glulisine in combination with Lantus in patients with type 1 diabetes. The studies were uncontrolled, meaning they did not use a randomized or double-blind design. NCT00546702 enrolled 142 patients in Russia, and NCT00545337 enrolled 60 patients in Ukraine.