drugset / Trial / NCT00046150

12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.

NCT00046150

Phase 3 Completed 59 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.

Timeline

Start
2002-05
Primary completion
Completion
2002-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous