drugset / Trial / NCT00526513

Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus

NCT00526513

Phase 4 Completed 188 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objectives: To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG \& PPBG) from baseline to the end of the study. Secondary Objectives: To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the incidence of hypoglycemia and other adverse events.

Timeline

Start
2007-07
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous

Indications