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insulin glargine U200 HOE901

Phase 1

Type 1 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Dec 24, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

insulin glargine U200 HOE901 · 1 trial · 1 indication

Phase 1 1
NCT02201199Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With LantusType 1 Diabetes Mellitus
COMPLETED36 Analytics
PHASE1COMPLETED
Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus
Type 1 Diabetes Mellitus
NCT0220119936
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Study Endpoints

Primary Endpoints

Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing
12 hours

Secondary Endpoints

INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)
36 hours
AUC up to the last measurable concentration
36 hours
Time to reach 50% of INS-AUC 0-36
36 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
insulin glargine U100ACTIVE_COMPARATOR1 single dose
insulin glargine U200EXPERIMENTAL1 single dose
insulin glargine U500EXPERIMENTAL1 single dose

Interventions

NameTypeDescription
insulin glargine U200 HOE901DRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
insulin glargine U500 HOE901DRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
insulin glargine U100 HOE901DRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Male or female subjects, between 18 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the American Diabetes Association. * Total insulin dose \<1.2 U/kg/day. * Minimum usual basal insulin dose ≥0.2 U/kg/day. * Body weight betwe...

Countries:Germany
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