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Last Updated: January 17, 2022

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CLINICAL TRIALS PROFILE FOR HUMALOG PEN

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505(b)(2) Clinical Trials for Humalog Pen

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 NCT04161976 ↗ A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus Completed Eli Lilly and Company Phase 1 2019-12-27 The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Humalog Pen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00046501 ↗ Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents Completed Sanofi Phase 3 2002-11-01 The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Humalog Pen

Condition Name

Condition Name for Humalog Pen
Intervention Trials
Type 1 Diabetes Mellitus 27
Diabetes Mellitus, Type 1 25
Diabetes Mellitus, Type 2 20
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Condition MeSH

Condition MeSH for Humalog Pen
Intervention Trials
Diabetes Mellitus 116
Diabetes Mellitus, Type 1 72
Diabetes Mellitus, Type 2 38
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Clinical Trial Locations for Humalog Pen

Trials by Country

Trials by Country for Humalog Pen
Location Trials
United States 563
Germany 59
China 50
United Kingdom 27
Australia 26
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Trials by US State

Trials by US State for Humalog Pen
Location Trials
California 43
Texas 30
Georgia 29
Florida 29
Washington 22
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Clinical Trial Progress for Humalog Pen

Clinical Trial Phase

Clinical Trial Phase for Humalog Pen
Clinical Trial Phase Trials
Phase 4 35
Phase 3 30
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Humalog Pen
Clinical Trial Phase Trials
Completed 125
Terminated 6
Withdrawn 5
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Clinical Trial Sponsors for Humalog Pen

Sponsor Name

Sponsor Name for Humalog Pen
Sponsor Trials
Eli Lilly and Company 51
Adocia 17
Sanofi 13
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Sponsor Type

Sponsor Type for Humalog Pen
Sponsor Trials
Industry 131
Other 57
NIH 3
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