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Glargine insulin

Phase 4

Cystic Fibrosis Related Diabetes | Small molecule | Metabolic |Sanofi|Trials Updated: Sep 22, 2005

Glargine insulin development status

Highest phase Phase 4 (NCT01203774)
Phase scored for SNYPhase 3
Registered trials 5 across 5 sponsors since Jul 2006

Glargine insulin target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Glargine insulin clinical trials

Glargine insulin · 1 trial · 1 indication

Phase 3 1
NCT00222521Insulin Glargine Vs Standard Insulin TherapyCystic Fibrosis Related Diabetes
COMPLETED20 Analytics
PHASE3COMPLETED
Insulin Glargine Vs Standard Insulin Therapy
Cystic Fibrosis Related DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Hemoglobin A1c

Secondary Endpoints

BMI
Body composition by DEXA Scan
# Episodes of illness
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Glargine insulinDRUG -
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

1. Inclusion Criteria 1. CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl) 1. . The diagnosis must be made at a time when the patient is in his/her basal state of health with no evidence of acute exacerbation in the preceding two months. a). Acute exacerbation ...

Countries:United States
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Frequently asked questions about Glargine insulin

What is glargine insulin used for in cystic fibrosis related diabetes?

Glargine insulin is being studied for the treatment of cystic fibrosis related diabetes, a form of diabetes that develops in people with cystic fibrosis. It is a long-acting insulin product developed by Sanofi, and the company has evaluated it in a Phase 3 clinical trial in this indication.

How does glargine insulin work?

Glargine insulin works as an agonist at the insulin receptor, known as INSR. By activating this receptor, it produces a prolonged, relatively steady glucose-lowering effect intended to mimic the body's baseline insulin supply. This contrasts with short-acting insulins given around meals.

Who makes glargine insulin?

Glargine insulin is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the drug in cystic fibrosis related diabetes.

What phase is glargine insulin in for cystic fibrosis related diabetes?

Glargine insulin is in Phase 3 development for cystic fibrosis related diabetes. It is an investigational use of the drug in this specific patient population, and the Phase 3 trial in this indication has been completed.

What clinical trials is glargine insulin in for cystic fibrosis related diabetes?

Glargine insulin has been studied in the Phase 3 trial NCT00222521, titled Insulin Glargine Vs Standard Insulin Therapy. That completed study enrolled 20 participants with cystic fibrosis related diabetes in the United States, including patients aged 12 years and older, and it was randomized but not double blinded.