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Glargine

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01153100Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip TherapyPHASE1 COMPLETED 60Apr 1, 2010Feb 1, 2012Nov 1, 20191 United States
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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 — 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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