drugset / Trial / NCT00297583

Insulin Glulisine in Type 1 Diabetes Mellitus

NCT00297583

Phase 1 Completed Sanofi
RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of the study was to compare the effect of insulin glulisine, insulin lispro and unmodified human insulin on endogenous glucose production during euglycemic glucose clamps using stable labeled glucose in type 1 diabetic subjects. The secondary objectives of the study were to assess: * the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma nonesterified free fatty acids (NEFA) and glycerol levels * the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma lactate levels * the safety and tolerability of insulin glulisine in comparison to insulin lispro and unmodified human insulin.

Timeline

Start
2004-04
Primary completion
2004-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic