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Last Updated: May 15, 2021

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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
NCT00394407 Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes Completed Sanofi Phase 4 2005-09-01 High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for APIDRA

Condition Name

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

Condition MeSH for APIDRA
Intervention Trials
Diabetes Mellitus 41
Diabetes Mellitus, Type 2 23
Diabetes Mellitus, Type 1 14
Hyperglycemia 7
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Clinical Trial Locations for APIDRA

Trials by Country

Trials by Country for APIDRA
Location Trials
United States 126
Germany 6
United Kingdom 3
France 3
Egypt 3
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for APIDRA
Clinical Trial Phase Trials
Phase 4 27
Phase 3 9
Phase 2 5
[disabled in preview] 14
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Clinical Trial Status

Clinical Trial Status for APIDRA
Clinical Trial Phase Trials
Completed 31
Recruiting 6
Not yet recruiting 5
[disabled in preview] 11
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Clinical Trial Sponsors for APIDRA

Sponsor Name

Sponsor Name for APIDRA
Sponsor Trials
Sanofi 36
Emory University 5
Halozyme Therapeutics 4
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Sponsor Type

Sponsor Type for APIDRA
Sponsor Trials
Industry 43
Other 35
NIH 1
[disabled in preview] 1
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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Dow
AstraZeneca

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