drugset / Trial / NCT01146678

Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1

NCT01146678

Phase 1 Completed 22 enrolled Sanofi
RandomizedCrossoverOpen-labelTreatment

Summary

Primary Objective: * to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: * to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug * to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix

Timeline

Start
2010-06
Primary completion
2010-09
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lixisenatide Peptide 20 ug Subcutaneous
Subject insulin glargine Protein / enzyme biologic 0.6 iu/kg Subcutaneous