drugset / Trial / NCT00360698

Insulin Glulisine in Type 2 Diabetic Patients

NCT00360698 ↗

Phase 4 Completed 106 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Timeline

Start
2006-07
Primary completion
2008-08
Completion
2008-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride vs Insulin Glargine+Metformin+Glimepiride; p = 0.0499; Risk Difference (RD) 13.68 (95% CI 0.01 to 28.37); Chi-squared NCT00360698 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic — —
Subject insulin glargine Protein / enzyme biologic — —
Background Glimepiride Small molecule — —
Background Metformin Small molecule — —