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CLINICAL TRIALS PROFILE FOR INSULIN ASPART RECOMBINANT

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505(b)(2) Clinical Trials for Insulin Aspart Recombinant

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	NCT01487811	Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers	Completed	Novo Nordisk A/S	Phase 1	2005-05-01	This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

All Clinical Trials for Insulin Aspart Recombinant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00046150	12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.	Completed	Sanofi	Phase 3	2002-05-01	The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.
NCT00065130	Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes	Completed	Novo Nordisk A/S	Phase 3	2000-04-01	This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.
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.

Clinical Trial Conditions for Insulin Aspart Recombinant

Condition Name

Condition Name for Insulin Aspart Recombinant
Intervention	Trials
Diabetes	252
Diabetes Mellitus, Type 2	157
Diabetes Mellitus, Type 1	121

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Condition MeSH

Condition MeSH for Insulin Aspart Recombinant
Intervention	Trials
Diabetes Mellitus	316
Diabetes Mellitus, Type 2	191
Diabetes Mellitus, Type 1	158

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Clinical Trial Locations for Insulin Aspart Recombinant

Trials by Country

Trials by Country for Insulin Aspart Recombinant
Location	Trials
United States	923
Germany	80
China	60
India	54
Canada	36

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Trials by US State

Trials by US State for Insulin Aspart Recombinant
Location	Trials
California	56
Texas	54
Florida	46
Georgia	40
New York	39

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Clinical Trial Progress for Insulin Aspart Recombinant

Clinical Trial Phase

Clinical Trial Phase for Insulin Aspart Recombinant
Clinical Trial Phase	Trials
Phase 4	114
Phase 3	96
Phase 2/Phase 3	3

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Clinical Trial Status

Clinical Trial Status for Insulin Aspart Recombinant
Clinical Trial Phase	Trials
Completed	293
Recruiting	34
Not yet recruiting	17

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Clinical Trial Sponsors for Insulin Aspart Recombinant

Sponsor Name

Sponsor Name for Insulin Aspart Recombinant
Sponsor	Trials
Novo Nordisk A/S	271
Sanofi	16
Eli Lilly and Company	8

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Sponsor Type

Sponsor Type for Insulin Aspart Recombinant
Sponsor	Trials
Industry	333
Other	141
U.S. Fed	3

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