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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR APIDRA


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All Clinical Trials for APIDRA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00115570 ↗ 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.
NCT00135083 ↗ 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.
NCT00135096 ↗ 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.
NCT00311077 ↗ 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 Biostator™. 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.
NCT00384085 ↗ Insulin Glargine "All to Target" Trial Completed Sanofi Phase 4 2006-05-01 The primary objectives were: - To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%) at Week 60 - To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for APIDRA

Condition Name

Condition Name for APIDRA
Intervention Trials
Diabetes Mellitus, Type 1 8
Diabetes Mellitus, Type 2 7
Type 2 Diabetes 6
Type 2 Diabetes Mellitus 6
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Condition MeSH

Condition MeSH for APIDRA
Intervention Trials
Diabetes Mellitus 42
Diabetes Mellitus, Type 2 23
Diabetes Mellitus, Type 1 17
Hyperglycemia 7
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Clinical Trial Locations for APIDRA

Trials by Country

Trials by Country for APIDRA
Location Trials
United States 131
Germany 6
Canada 3
United Kingdom 3
France 3
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Trials by US State

Trials by US State for APIDRA
Location Trials
California 9
Georgia 8
Minnesota 7
Florida 7
Texas 6
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Clinical Trial Progress for APIDRA

Clinical Trial Phase

Clinical Trial Phase for APIDRA
Clinical Trial Phase Trials
Phase 4 28
Phase 3 10
Phase 2/Phase 3 1
[disabled in preview] 10
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Clinical Trial Status

Clinical Trial Status for APIDRA
Clinical Trial Phase Trials
Completed 42
Terminated 6
Unknown status 5
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Clinical Trial Sponsors for APIDRA

Sponsor Name

Sponsor Name for APIDRA
Sponsor Trials
Sanofi 37
Emory University 5
Halozyme Therapeutics 4
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Sponsor Type

Sponsor Type for APIDRA
Sponsor Trials
Industry 45
Other 39
U.S. Fed 1
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