CLINICAL TRIALS PROFILE FOR NOVOLOG
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505(b)(2) Clinical Trials for Novolog
| 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. |
| >Trial Type | >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. |
| NCT00097279 ↗ | Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes | Completed | Novo Nordisk A/S | Phase 3 | 2004-08-01 | This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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