CLINICAL TRIALS PROFILE FOR NOVOLOG
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Biosimilar Clinical Trials for NOVOLOG
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for NOVOLOG
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| 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). |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for NOVOLOG
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