Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents
Completed
Sanofi
Phase 3
2005-04-01
The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and
effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with
type 1 diabetes mellitus.
Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus
Completed
Sanofi
Phase 3
2004-08-01
The purpose of this study is to show the non-inferiority of insulin glulisine administered
with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c
(HbA1c), from baseline to study week 24.
Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
Completed
Sanofi
Phase 3
2004-08-01
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.
Insulin Glulisine in Healthy Lean and Obese Subjects
Completed
Sanofi
Phase 1
2004-04-01
Primary objective
- To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration
of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin
glulisine across healthy subjects in 4 different BMI-classes (lean, overweight,
moderately obese, severely obese), using the euglycemic clamp technique with the
Biostatorâ„¢.
Secondary objective
- To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous
administration of insulin glulisine in comparison to insulin lispro and to investigate
the safety and tolerability after subcutaneous administration of insulin glulisine in
comparison to insulin lispro.
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