drugset / Trial / NCT00135096

Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

NCT00135096 ↗

Phase 3 Completed 345 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.

Timeline

Start
2004-08
Primary completion
—
Completion
2007-07

Outcome

Met primary endpoint

paper Postprandial glulisine administration provided similar glycaemic control and was non-inferior to preprandial administration on weight gain PMID 21812890 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic — Subcutaneous
Background insulin glargine Protein / enzyme biologic — —