Drugs / Insulatard
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Insulatard | — | 2002-10-07 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01756105 | Jun 2012 → Feb 2018 | gestational diabetes | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00329615 | Jan 2000 → Sep 2005 | — | Göteborg University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00506194 | Oct 2005 → Aug 2007 | type 2 diabetes mellitus | Taipei Veterans General Hospital, Taiwan | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT00830297 Comparator | Jan 2009 → Dec 2010 | hyperglycemia | Marcus Saemann | Completed | No outcome recorded |
| Phase 4 | NCT06855615 Comparator | Oct 2020 → Jan 2021 | type 2 diabetes mellitus | Hospital Sultanah Aminah Johor Bahru | Completed | No outcome recorded |
| Phase 4 | NCT00788840 Comparator | Jan 2008 → Aug 2009 | obesity disorder, type 2 diabetes mellitus | University of Surrey | Completed | No outcome recorded |
| Phase 4 | NCT00566124 Comparator | Jan → May 2005 | diabetes mellitus | University of Aarhus | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Insulatard | “Insulin therapy was initiated at a 75% total daily dose in the last day hospitalization with Insulatard.” NCT00506194 ↗6“introduce NPH Insulin (Umuline NPH\*, insulatard\*) before sleeping” NCT01756105 ↗ |
| Modality | Protein / enzyme biologic | “Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.” NCT00788840 ↗ |
| Route | Subcutaneous | “injected s.c. in the thigh” NCT00566124 ↗ |