insulin NPH
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT00760448 | Apr 2004 → Oct 2005 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01497600 | Feb → Aug 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01542450 | Aug 2002 → Feb 2003 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 314 trials · 3 met primary | ||||||
| Phase 3 | NCT02131272 | Jun 2014 → Jun 2016 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 3 | NCT00435019 | Feb 2007 → Sep 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00383877 | Sep 2006 → Aug 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00504673 | Apr 2005 → Dec 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00104182 | Feb 2005 → Feb 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00184665 | Jun 2004 → Sep 2006 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00605137 | May 2004 → Apr 2005 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00600626 | Jan → Jul 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00595374 | Dec 2003 → Oct 2004 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00604253 | Dec 2003 → May 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00604344 | Apr 2003 → Mar 2005 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00604396 | Mar 2003 → Jan 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00312156 | Aug 2002 → Aug 2003 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01562561 | Jun 2001 → Dec 2002 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT00509925 | Jul 2007 → Jul 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 4 | NCT00313742 | Apr → Nov 2006 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00494988 | Dec 2004 → Apr 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00799448 | Sep 2003 → Sep 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00121966 | Jan 2003 → Jul 2007 | type 2 diabetes mellitus | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00597233 | Oct → Dec 2002 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT01497561 Comparator | Mar → Jun 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT05124457 Comparator | Feb 2022 → Jun 2025 overdue | gestational diabetes, type 2 diabetes mellitus | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 2 | NCT00660374 Comparator | Feb 2008 → Mar 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT06619301 Comparator | Apr 2024 → Apr 2026 overdue | gestational diabetes, type 2 diabetes mellitus | Loyola University | Recruiting | No outcome recorded |
| Phase 3 | NCT00725036 Background | Sep 2002 → Dec 2004 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01486940 Comparator | Mar → Oct 2002 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01697657 Comparator | Sep 2001 → Nov 2002 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00065130 Background | Apr 2000 → Dec 2003 | gestational diabetes | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00832182 Background | Dec 1999 → Nov 2002 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01707134 Background | Sep 1997 → May 2000 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01486966 Comparator | Nov 2011 → Jun 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01832935 Comparator | Jul 2011 → Jul 2012 | type 2 diabetes mellitus | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00795600 Comparator | Apr 2009 → Aug 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 4 | NCT00506662 Comparator | Jul 2007 → Dec 2008 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 4 | NCT00593255 Background | Jul 2004 → Apr 2005 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| — | NCT00925977 Comparator | Jul 2009 → Feb 2012 | type 1 diabetes mellitus | Rabin Medical Center | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2015-06-06 | Eli Lilly and Company | Results Lilly's Basal Insulin Peglispro Shows Superiority to Insulin Glargine in Reducing HbA1c in People with Type 2 Diabetes lilly.com ↗
However, the proportion of BIL patients that had ALT levels greater than or equal to three times the upper limit of the normal range (ALT≥3X ULN) was similar to patients treated with NPH insulin. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-06-06 | Eli Lilly and Company | Lilly's Basal Insulin Peglispro Shows Superiority to Insulin Glargine in Reducing HbA1c in People with Type 2 Diabetes lilly.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin NPH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00725036 ↗ |
| Known as | human isophane insulin | “AIMS: To show that a thrice daily meal-time biphasic insulin aspart (BIAsp) treatment regimen is as efficacious as a 4 times daily basal-bolus regimen with human isophane...” PMID 17115349 ↗ Oct 20061“(Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.” PMID 33166419 ↗ Nov 2020 |
| Known as | Insulin isophane | “Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks” NCT00795600 ↗ |
| Known as | insulin Neutral Protamine Hagedorn | “insulin NPH (insulin Neutral Protamine Hagedorn)” NCT01562561 ↗ |
| Known as | neutral protamine Hagedorn | “This randomised (1:1), multinational, open-labelled, parallel group trial compared insulin detemir (IDet) with neutral protamine Hagedorn (NPH) insulin, in combination with...” PMID 21418455 ↗ Mar 20114“This study compared the efficacy and safety of insulin detemir versus neutral protamine Hagedorn (NPH) insulin, both in combination with metformin and lifestyle intervention,...” PMID 30014302 ↗ Jul 2018 “We compared the symptoms of hypoglycaemia induced by insulin detemir (NN304) (B29Lys(epsilon-tetradecanoyl),desB30 human insulin) and equally effective doses of neutral...” PMID 19707744 ↗ Aug 2009 “Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks” NCT00795600 ↗ “NPH (neutral protamine Hagedorn) insulin (human isophane insulin)” PMID 33166419 ↗ Nov 2020 |
| Known as | Neutral Protamine Hagedorn human isophane | “with that of Neutral Protamine Hagedorn human isophane (NPH) insulin, both combined with insulin aspart” PMID 17227321 ↗ Jan 2007 |
| Known as | neutral protamine Hagedorn insulin | “AIMS: This 24-month, multi-national, open-label, parallel group trial investigated the long-term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin...” PMID 18387078 ↗ Apr 20081“To assess weight change when once-daily insulin detemir (detemir) or neutral protamine Hagedorn insulin (NPH) are used in already overweight Type 2 diabetes patients requiring...” PMID 18959604 ↗ Aug 2008 |
| Known as | Novolin N | “One Injection of Novolin® N at Bedtime” NCT00593255 ↗ |
| Known as | NPH | “The aim of this analysis was to evaluate the long-term clinical and economic outcomes associated with insulin detemir and neutral protamine Hagedorn (NPH) insulin in...” PMID 19545216 ↗ Jun 20094“This randomised (1:1), multinational, open-labelled, parallel group trial compared insulin detemir (IDet) with neutral protamine Hagedorn (NPH) insulin, in combination with...” PMID 21418455 ↗ Mar 2011 “AIMS: To show that a thrice daily meal-time biphasic insulin aspart (BIAsp) treatment regimen is as efficacious as a 4 times daily basal-bolus regimen with human isophane...” PMID 17115349 ↗ Oct 2006 “the long-acting insulin analogues insulin detemir (IDet) and NPH insulin (NPH)” PMID 16918592 ↗ Sep 2006 “compared with NPH insulin (NPH).” PMID 16842476 ↗ Jul 2006 |
| Known as | NPH Human Insulin | “A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir)...” NCT01542450 ↗ |
| Known as | NPH insulin | “The aim of this analysis was to evaluate the long-term clinical and economic outcomes associated with insulin detemir and neutral protamine Hagedorn (NPH) insulin in...” PMID 19545216 ↗ Jun 20098“This randomised (1:1), multinational, open-labelled, parallel group trial compared insulin detemir (IDet) with neutral protamine Hagedorn (NPH) insulin, in combination with...” PMID 21418455 ↗ Mar 2011 “This study compared the efficacy and safety of insulin detemir versus neutral protamine Hagedorn (NPH) insulin, both in combination with metformin and lifestyle intervention,...” PMID 30014302 ↗ Jul 2018 “using either the soluble long-acting basal insulin analogue, insulin detemir, in combination with the rapid-acting analogue, insulin aspart, or NPH insulin in combination with...” PMID 15298338 ↗ Apr 2004 “Patients were randomly assigned to receive an evening SC injection of detemir, a prebreakfast injection of detemir, or an evening injection of NPH insulin (1:1:1), administered...” PMID 17157113 ↗ Oct 2006 “We compared the symptoms of hypoglycaemia induced by insulin detemir (NN304) (B29Lys(epsilon-tetradecanoyl),desB30 human insulin) and equally effective doses of neutral...” PMID 19707744 ↗ Aug 2009 “(Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.” PMID 33166419 ↗ Nov 2020 “with NPH insulin as basal insulin” PMID 16054266 ↗ Jul 2005 “compared with NPH insulin (NPH).” PMID 16842476 ↗ Jul 2006 |
| Modality | Protein / enzyme biologic | “Neutral Protamine Hagedorn insulin” PMID 18387078 ↗ Apr 2008 |
| Route | Subcutaneous | “injection s.c.” NCT00660374 ↗ |