Drugs / Humulin N
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HUMULIN N | — | 1982-10-28 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04022304 | Jun → Dec 2019 | — | Biocon Limited | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00046501 | Nov 2002 → Feb 2005 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01613807 | Oct 2008 → Jun 2010 | gestational diabetes | Sansum Diabetes Research Institute | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT05768191 Comparator | Jun 2023 → Apr 2024 | type 1 diabetes mellitus | Nazi Boni University | Completed | No outcome recorded |
| Phase 4 | NCT01270191 Comparator | Nov 2010 → Dec 2014 | type 2 diabetes mellitus | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Humulin N | “3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime” NCT01613807 ↗ |
| Known as | insulin human isophane suspension | “10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals.” NCT05768191 ↗ |
| Modality | Protein / enzyme biologic | “Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin.” NCT04022304 ↗ |
| Route | Subcutaneous | “0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.” NCT04022304 ↗ |