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Last Updated: March 28, 2024

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 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 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.
NCT00191282 ↗ Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes Completed Eli Lilly and Company Phase 4 2002-10-01 The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event (primary outcome defined as CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalized acute coronary syndrome).
NCT00191581 ↗ Local Registration Trial in China Humalog Mix 50 Completed Eli Lilly and Company Phase 3 2005-03-01 The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.
NCT00206401 ↗ Lantus in the Treatment of Type 1 Diabetes Children Completed Baylor College of Medicine Phase 4 2004-11-01 In this study, we plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected separately) or on intensive insulin management (IIM-several shots of short acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be used to monitor blood glucose control over a 6 month period. Twice during the course of the study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records blood sugar readings every 5 minutes) will be used to record all the changes in the blood glucose levels occurring over a 72-hour period.
>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 27
Diabetes Mellitus, Type 1 27
Diabetes Mellitus, Type 2 20
Type 2 Diabetes Mellitus 16
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Condition MeSH

Condition MeSH for Humalog Tempo Pen
Intervention Trials
Diabetes Mellitus 122
Diabetes Mellitus, Type 1 76
Diabetes Mellitus, Type 2 40
Hyperglycemia 15
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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 576
Germany 67
China 50
Spain 32
Canada 27
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Trials by US State

Trials by US State for Humalog Tempo Pen
Location Trials
California 43
Texas 31
Florida 30
Georgia 29
Washington 23
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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 36
Phase 3 31
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Humalog Tempo Pen
Clinical Trial Phase Trials
Completed 125
Not yet recruiting 8
Terminated 6
[disabled in preview] 14
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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 53
Adocia 20
Sanofi 13
[disabled in preview] 30
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Sponsor Type

Sponsor Type for Humalog Tempo Pen
Sponsor Trials
Industry 140
Other 62
NIH 3
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