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Glargine

Phase 4

Diabetes | Small molecule | Metabolic |Sanofi|Trials Updated: Nov 1, 2019

Glargine development status

Highest phase Phase 4 (NCT01240200)
Phase scored for SNYPhase 1
Registered trials 28 across 8 sponsors since Oct 2007

Glargine target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as Lantus

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Glargine clinical trials

Glargine · 1 trial · 1 indication

Phase 1 1
NCT01153100Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip TherapyDiabetes
COMPLETED60 Analytics
PHASE1COMPLETED
Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)
within 48 hours of discontinuation

Secondary Endpoints

Reduction in duration of insulin drip therapy and reduction in total and average per hour insulin drip dose
within one week of insulin drip therapy
Reduction in ICU length of stay
within two weeks of hospitalization
Equal or improved diabetes control
within two weeks of hospitalization
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard insulin drip therapyNO_INTERVENTIONStandard insulin drip therapy
Insulin drip and glargineACTIVE_COMPARATORInsulin drip and glargine 0.25 units per kg body weight

Interventions

NameTypeDescription
GlargineDRUGGlargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
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Eligibility Criteria

Age Range19 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip. * Patients with type 1 an...

Countries:United States
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Competitive Landscape -Diabetes Complications 8 trials (matched to "Diabetes")

No competing companies are currently tracked in active development for Diabetes Complications.
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Frequently asked questions about Glargine

What is Glargine used for?

Glargine is being studied for the treatment of diabetes. It is a long-acting insulin therapy developed by Sanofi. The clinical program has focused on evaluating its use in diabetes management, including a completed Phase 1 trial that examined adding subcutaneous long-acting Glargine to insulin drip therapy compared with standard insulin drip therapy.

How does Glargine work?

Glargine acts as an agonist at the insulin receptor (INSR). By binding to and activating INSR, it mimics the action of endogenous insulin, supporting glucose uptake and regulation. This mechanism underlies its development as a long-acting insulin therapy for diabetes.

Who makes Glargine?

Glargine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for the clinical development of this long-acting insulin candidate for diabetes.

What phase is Glargine in?

Glargine is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program includes one completed trial evaluating its use in diabetes.

What clinical trials is Glargine in?

Glargine has been evaluated in one completed Phase 1 trial, NCT01153100, titled "Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy." The trial enrolled 60 participants with diabetes in the United States and used an active-controlled, randomized design.