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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR INSULIN GLULISINE RECOMBINANT

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Clinical Trials for Insulin Glulisine Recombinant

Trial ID Title Status Sponsor Phase Summary
NCT00115570 Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents Completed Sanofi Phase 3 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.
NCT00135057 Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin Completed Sanofi Phase 3 The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.
NCT00135083 Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus Completed Sanofi Phase 3 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 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.
NCT00135941 Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2) Completed Sanofi Phase 3 The purpose of this study is to test for superiority in improvements from baseline in patient reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.
NCT00174642 Opposing Step-by-step Insulin Reinforcement to Intensified Strategy Completed Sanofi Phase 3 Primary objectives : - To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. - To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. Secondary objectives : - To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Insulin Glulisine Recombinant

Condition Name

Condition Name for Insulin Glulisine Recombinant
Intervention Trials
Diabetes Mellitus, Type 2 19
Diabetes Mellitus, Type 1 12
Type 2 Diabetes 9
Diabetes Mellitus 7
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Condition MeSH

Condition MeSH for Insulin Glulisine Recombinant
Intervention Trials
Diabetes Mellitus 67
Diabetes Mellitus, Type 2 36
Diabetes Mellitus, Type 1 24
Hyperglycemia 8
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Clinical Trial Locations for Insulin Glulisine Recombinant

Trials by Country

Trials by Country for Insulin Glulisine Recombinant
Location Trials
United States 127
Germany 11
Russian Federation 7
Poland 7
United Kingdom 7
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Trials by US State

Trials by US State for Insulin Glulisine Recombinant
Location Trials
Georgia 10
California 8
Minnesota 8
Florida 8
New Jersey 8
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Clinical Trial Progress for Insulin Glulisine Recombinant

Clinical Trial Phase

Clinical Trial Phase for Insulin Glulisine Recombinant
Clinical Trial Phase Trials
Phase 4 42
Phase 3 23
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Insulin Glulisine Recombinant
Clinical Trial Phase Trials
Completed 64
Terminated 6
Unknown status 6
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Clinical Trial Sponsors for Insulin Glulisine Recombinant

Sponsor Name

Sponsor Name for Insulin Glulisine Recombinant
Sponsor Trials
Sanofi 59
Emory University 6
Halozyme Therapeutics 4
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Sponsor Type

Sponsor Type for Insulin Glulisine Recombinant
Sponsor Trials
Industry 78
Other 51
U.S. Fed 1
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Serving hundreds of leading biopharmaceutical companies globally:

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