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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR INSULIN ASPART; INSULIN DEGLUDEC


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Biosimilar Clinical Trials for insulin aspart; insulin degludec

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
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; insulin degludec

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00612040 ↗ Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes Completed Novo Nordisk A/S Phase 2 2008-01-01 This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
NCT00613951 ↗ Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes Completed Novo Nordisk A/S Phase 2 2008-01-01 This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.
NCT00614055 ↗ Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Completed Novo Nordisk A/S Phase 2 2008-01-01 This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
NCT00842361 ↗ Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus Completed Novo Nordisk A/S Phase 2 2009-01-01 This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.
NCT00972283 ↗ Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes Completed Novo Nordisk A/S Phase 3 2009-09-01 This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.
NCT00978627 ↗ Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes Completed Novo Nordisk A/S Phase 3 2009-08-01 This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for insulin aspart; insulin degludec

Condition Name

Condition Name for insulin aspart; insulin degludec
Intervention Trials
Diabetes 48
Diabetes Mellitus, Type 1 23
Diabetes Mellitus, Type 2 23
Healthy 5
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Condition MeSH

Condition MeSH for insulin aspart; insulin degludec
Intervention Trials
Diabetes Mellitus 50
Diabetes Mellitus, Type 2 27
Diabetes Mellitus, Type 1 27
Gastroparesis 1
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Clinical Trial Locations for insulin aspart; insulin degludec

Trials by Country

Trials by Country for insulin aspart; insulin degludec
Location Trials
United States 365
India 58
China 39
Canada 33
Germany 24
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Trials by US State

Trials by US State for insulin aspart; insulin degludec
Location Trials
California 21
Florida 19
Texas 19
New York 16
North Carolina 15
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Clinical Trial Progress for insulin aspart; insulin degludec

Clinical Trial Phase

Clinical Trial Phase for insulin aspart; insulin degludec
Clinical Trial Phase Trials
Phase 4 4
Phase 3 29
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for insulin aspart; insulin degludec
Clinical Trial Phase Trials
Completed 52
Recruiting 4
Not yet recruiting 2
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Clinical Trial Sponsors for insulin aspart; insulin degludec

Sponsor Name

Sponsor Name for insulin aspart; insulin degludec
Sponsor Trials
Novo Nordisk A/S 52
Beijing Hospital 1
Steno Diabetes Center Copenhagen 1
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Sponsor Type

Sponsor Type for insulin aspart; insulin degludec
Sponsor Trials
Industry 53
Other 17
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