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Last Updated: October 31, 2020

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CLINICAL TRIALS PROFILE FOR INSULIN LISPRO

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505(b)(2) Clinical Trials for Insulin Lispro

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 NCT02942654 A Study of LY900014 Formulation in Healthy Participants Recruiting Eli Lilly and Company Phase 1 2016-11-01 This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
New Formulation NCT03232983 A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants Not yet recruiting Eli Lilly and Company Phase 1 2017-08-01 This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm. The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream. Side effects and tolerability will be documented. The study will last for about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
New Formulation NCT04049123 A Study of LY900014 in Healthy Chinese Participants Not yet recruiting Eli Lilly and Company Phase 1 2019-10-15 The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the affect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.
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 Insulin Lispro

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00036504 Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin Completed Eli Lilly and Company Phase 4 2001-08-01 The purposes of this study are to determine: 1. If patients taking insulin lispro LM with metformin will have better overall control of their blood sugar than patients taking a long acting insulin comparator with metformin. 2. If there is a difference in the way the two treatments affect blood sugar control before and after meals and at night. 3. If there is a difference in the insulin dose required with the two treatments. 4. If there is a difference in the numbers of times patients experience low blood sugar with the two treatments. 5. If there is a difference in the effect on patients's body weight.
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.
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.
NCT00110370 Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes Completed Eli Lilly and Company Phase 4 2004-04-01 The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Lispro

Condition Name

Condition Name for Insulin Lispro
Intervention Trials
Diabetes Mellitus, Type 2 36
Diabetes Mellitus, Type 1 36
Type 1 Diabetes Mellitus 34
Diabetes Mellitus 18
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Condition MeSH

Condition MeSH for Insulin Lispro
Intervention Trials
Diabetes Mellitus 172
Diabetes Mellitus, Type 1 97
Diabetes Mellitus, Type 2 65
Hyperglycemia 9
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Clinical Trial Locations for Insulin Lispro

Trials by Country

Trials by Country for Insulin Lispro
Location Trials
United States 759
Germany 87
Canada 42
China 40
United Kingdom 33
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Trials by US State

Trials by US State for Insulin Lispro
Location Trials
California 48
Texas 39
Florida 38
Georgia 31
North Carolina 29
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Clinical Trial Progress for Insulin Lispro

Clinical Trial Phase

Clinical Trial Phase for Insulin Lispro
Clinical Trial Phase Trials
Phase 4 52
Phase 3 52
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Insulin Lispro
Clinical Trial Phase Trials
Completed 137
Not yet recruiting 34
Recruiting 17
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Clinical Trial Sponsors for Insulin Lispro

Sponsor Name

Sponsor Name for Insulin Lispro
Sponsor Trials
Eli Lilly and Company 87
Sanofi 24
Adocia 17
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Sponsor Type

Sponsor Type for Insulin Lispro
Sponsor Trials
Industry 201
Other 70
U.S. Fed 1
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