drugset / Trial / NCT01493115

Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

NCT01493115

Phase 1 Completed 18 enrolled Sanofi
RandomizedCrossoverDouble-blindTreatment

Summary

Primary Objective: To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® Secondary Objective: To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation

Timeline

Start
2011-11
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic Subcutaneous