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Glargine

Phase 1

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

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

Clinical trial landscape

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 6 trials (matched to "Diabetes")

Frequently asked questions about Glargine

What is Glargine used for?

Glargine is an investigational small molecule being developed for the treatment of diabetes. It is a long-acting form of insulin designed to be added to insulin drip therapy. The drug is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.

Who makes Glargine?

Glargine 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 Glargine in patients with diabetes.

What phase is Glargine in?

Glargine is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and effectiveness in treating diabetes.

What clinical trials is Glargine in?

Glargine has been studied in one completed clinical trial, identified as NCT01153100. This Phase 1 trial enrolled 60 participants with diabetes in the United States and evaluated the effectiveness of adding subcutaneous long-acting Glargine to insulin drip therapy compared with standard insulin drip therapy.

Is Glargine the same as insulin glargine?

Glargine is a long-acting insulin formulation being developed by Sanofi. It is designed to provide a sustained release of insulin to help manage blood sugar levels in people with diabetes. The drug is currently in Phase 1 clinical trials and is not yet approved for commercial use.