Drugs / Lispro-PH20
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 0 | NCT01945099 | Sep 2013 → Dec 2015 | type 1 diabetes mellitus | Yale University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2012-06-11 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Formulations Improved Postprandial Glycemic Control in Patients Living with Type 1 Diabetes: Phase 2 Study Results Presented at ADA 2012 halozyme.com ↗
The study met its primary endpoint of A1C non-inferiority (A1C is a measure of average blood sugar over three months). |
| 2012-06-09 | Halozyme Therapeutics | Results Halozyme Presents Positive Data from Two Ultrafast Insulin Clinical Trials with Human Hyaluronidase Enzyme - rHuPH20 - at ADA 2012 halozyme.com ↗
The study met the primary endpoint of showing that the Analog-PH20 formulations were non-inferior for A1C compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.12, +.05). |
| 2011-10-21 | Halozyme Therapeutics | Results Halozyme Announces Positive Results From Phase 2 Ultrafast Insulin Trials in Patients with Type 1 and Type 2 Diabetes halozyme.com ↗
Both trials met the primary endpoint of non-inferiority of HbA1C compared to the insulin analog comparator, with superior reductions in post-prandial glucose excursions in the PH20 insulin analog arms. |
| 2009-06-06 | Halozyme Therapeutics | Results Halozyme's Phase 2 Insulin-PH20 Study Demonstrates Faster Insulin Absorption and Superior Glucose Control in Type 1 Diabetic Patients halozyme.com ↗
Study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal, with improvements in both peak glycemic response and total hyperglycemic exposure compared to Humalog alone. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2012-06-11 | Halozyme Therapeutics | Halozyme's Ultrafast Insulin Formulations Improved Postprandial Glycemic Control in Patients Living with Type 1 Diabetes: Phase 2 Study Results Presented at ADA 2012 halozyme.com ↗ |
| 2012-06-09 | Halozyme Therapeutics | Halozyme Presents Positive Data from Two Ultrafast Insulin Clinical Trials with Human Hyaluronidase Enzyme - rHuPH20 - at ADA 2012 halozyme.com ↗ |
| 2011-10-21 | Halozyme Therapeutics | Halozyme Announces Positive Results From Phase 2 Ultrafast Insulin Trials in Patients with Type 1 and Type 2 Diabetes halozyme.com ↗ |
| 2009-06-06 | Halozyme Therapeutics | Halozyme's Phase 2 Insulin-PH20 Study Demonstrates Faster Insulin Absorption and Superior Glucose Control in Type 1 Diabetic Patients halozyme.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lispro-PH20 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01945099 ↗ |