drugset / Trial / NCT01195454

Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®

NCT01195454

Phase 1 Completed 24 enrolled Sanofi
RandomizedCrossoverDouble-blindTreatment

Summary

Primary Objective: \- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus® Secondary Objectives: * To assess the exposure ratios of a new insulin glargine formulation versus Lantus® * To compare the duration of action of a new insulin glargine formulation versus Lantus® * To explore the dose response and dose exposure relationship of a new insulin glargine formulation * To assess the safety and tolerability of a new insulin glargine formulation

Timeline

Start
2010-08
Primary completion
2010-11
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic Subcutaneous