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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR INSULIN ASPART RECOMBINANT


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Biosimilar Clinical Trials for insulin aspart recombinant

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT05539872 ↗ Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers Recruiting Amphastar Pharmaceuticals, Inc. Phase 2/Phase 3 2022-08-22 This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
NCT05802862 ↗ A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China Not yet recruiting Sunshine Lake Pharma Co., Ltd. Phase 3 2023-05-01 The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).
>Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT00082407 ↗ Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin Completed Eli Lilly and Company Phase 3 2003-11-01 This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082407 ↗ Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin Completed AstraZeneca Phase 3 2003-11-01 This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00095082 ↗ Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes Completed Novo Nordisk A/S Phase 3 2004-09-01 This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for insulin aspart recombinant

Condition Name

Condition Name for insulin aspart recombinant
Intervention Trials
Diabetes 256
Diabetes Mellitus, Type 2 164
Diabetes Mellitus, Type 1 131
Type 1 Diabetes Mellitus 27
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Condition MeSH

Condition MeSH for insulin aspart recombinant
Intervention Trials
Diabetes Mellitus 343
Diabetes Mellitus, Type 2 202
Diabetes Mellitus, Type 1 184
Hyperglycemia 10
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Clinical Trial Locations for insulin aspart recombinant

Trials by Country

Trials by Country for insulin aspart recombinant
Location Trials
India 128
China 125
Germany 85
Canada 79
South Africa 55
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Trials by US State

Trials by US State for insulin aspart recombinant
Location Trials
California 65
Texas 63
Florida 53
Georgia 48
New York 47
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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 4 120
Phase 3 105
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for insulin aspart recombinant
Clinical Trial Phase Trials
Completed 348
Recruiting 24
Unknown status 17
[disabled in preview] 31
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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 282
Sanofi 17
Eli Lilly and Company 8
[disabled in preview] 22
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Sponsor Type

Sponsor Type for insulin aspart recombinant
Sponsor Trials
Industry 359
Other 187
U.S. Fed 4
[disabled in preview] 2
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