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Last Updated: August 6, 2020

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CLINICAL TRIALS PROFILE FOR NOVOLOG

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505(b)(2) Clinical Trials for Novolog

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01487811 Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers Completed Novo Nordisk A/S Phase 1 2005-05-01 This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Novolog

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00065130 Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes Completed Novo Nordisk A/S Phase 3 2000-04-01 This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.
NCT00071448 Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population Completed Novo Nordisk A/S Phase 3 2002-06-01 This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
NCT00082407 Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin Completed Eli Lilly and Company Phase 3 2003-11-01 This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082407 Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin Completed AstraZeneca Phase 3 2003-11-01 This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00095446 NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes Completed Novo Nordisk A/S Phase 4 2004-07-01 This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.
NCT00097071 Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents Completed Novo Nordisk A/S Phase 3 2004-10-01 This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.
NCT00097279 Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes Completed Novo Nordisk A/S Phase 3 2004-08-01 This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Novolog

Condition Name

Condition Name for Novolog
Intervention Trials
Diabetes 14
Type 1 Diabetes Mellitus 11
Diabetes Mellitus, Type 1 10
Diabetes Mellitus, Type 2 9
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Condition MeSH

Condition MeSH for Novolog
Intervention Trials
Diabetes Mellitus 43
Diabetes Mellitus, Type 1 27
Diabetes Mellitus, Type 2 19
Hyperglycemia 8
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Clinical Trial Locations for Novolog

Trials by Country

Trials by Country for Novolog
Location Trials
United States 266
Canada 5
Germany 5
Bulgaria 3
Puerto Rico 3
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Trials by US State

Trials by US State for Novolog
Location Trials
Texas 19
California 18
Georgia 14
New York 12
Florida 12
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Clinical Trial Progress for Novolog

Clinical Trial Phase

Clinical Trial Phase for Novolog
Clinical Trial Phase Trials
Phase 4 23
Phase 3 15
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Novolog
Clinical Trial Phase Trials
Completed 36
Recruiting 13
Not yet recruiting 7
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Clinical Trial Sponsors for Novolog

Sponsor Name

Sponsor Name for Novolog
Sponsor Trials
Novo Nordisk A/S 20
Sanofi 7
Emory University 7
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Sponsor Type

Sponsor Type for Novolog
Sponsor Trials
Industry 47
Other 35
NIH 2
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