CLINICAL TRIALS PROFILE FOR HUMALOG TEMPO PEN

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.

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.

Clinical Trial Conditions for Humalog Tempo Pen

Condition Name

Condition Name for Humalog Tempo Pen
Intervention	Trials
Diabetes Mellitus, Type 1	27
Type 1 Diabetes Mellitus	27
Diabetes Mellitus, Type 2	20
Type 2 Diabetes Mellitus	16

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

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
United Kingdom	27

Trials by US State

Trials by US State for Humalog Tempo Pen
Location	Trials
California	43
Texas	31
Florida	30
Georgia	29
Washington	23

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

Clinical Trial Status

Clinical Trial Status for Humalog Tempo Pen
Clinical Trial Phase	Trials
Completed	125
Not yet recruiting	8
Terminated	6

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

Sponsor Type

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