Study S000985

A Randomized, Cross-over, Open, Euglycemic Clamp Study on the Relative Bioavailability and Activity of 0.6 U/kg Insulin Glargine and 20 μg Lixisenatide, Given as On-site Mix Compared to Separate Simultaneous Injections in Subjects With Type 1 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT01146678
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 22
Start: 2010-06
Primary completion: 2010-09
Lead sponsor: Sanofi
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG:Insulin glargine HOE901; DRUG:Lixisenatide AVE0010
Results posted: FALSE
Secondary identifiers: EUDRACT_NUMBER:2010-019228-30; OTHER:U1111-1116-8960

Registered primary outcomes

Area under the plasma lixisenatide concentration curve (LIX-AUClast) [1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period]
Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax) [1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period]

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