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Last Updated: October 1, 2020

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CLINICAL TRIALS PROFILE FOR HUMALOG TEMPO PEN

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505(b)(2) Clinical Trials for Humalog Tempo 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 Not yet recruiting Eli Lilly and Company Phase 1 2019-12-16 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 Tempo 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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Humalog Tempo Pen

Condition Name

Condition Name for Humalog Tempo Pen
Intervention Trials
Type 1 Diabetes Mellitus 24
Diabetes Mellitus, Type 1 22
Diabetes Mellitus, Type 2 20
Type 2 Diabetes Mellitus 14
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Condition MeSH

Condition MeSH for Humalog Tempo Pen
Intervention Trials
Diabetes Mellitus 108
Diabetes Mellitus, Type 1 65
Diabetes Mellitus, Type 2 36
Hyperglycemia 14
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Clinical Trial Locations for Humalog Tempo Pen

Trials by Country

Trials by Country for Humalog Tempo Pen
Location Trials
United States 489
Germany 43
China 35
Canada 24
Australia 22
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Trials by US State

Trials by US State for Humalog Tempo Pen
Location Trials
California 36
Florida 26
Texas 26
Georgia 25
Colorado 20
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Clinical Trial Progress for Humalog Tempo Pen

Clinical Trial Phase

Clinical Trial Phase for Humalog Tempo Pen
Clinical Trial Phase Trials
Phase 4 31
Phase 3 28
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Humalog Tempo Pen
Clinical Trial Phase Trials
Completed 85
Not yet recruiting 19
Recruiting 17
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Clinical Trial Sponsors for Humalog Tempo Pen

Sponsor Name

Sponsor Name for Humalog Tempo Pen
Sponsor Trials
Eli Lilly and Company 46
Adocia 17
Sanofi 13
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Sponsor Type

Sponsor Type for Humalog Tempo Pen
Sponsor Trials
Industry 122
Other 45
NIH 1
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