Drugs / Insulin Peglispro
last change Nov 2017 re-read 9 days ago

Insulin Peglispro

English name insulin peglispro

Protein / enzyme biologic targets INSR via activation

Developed for
type 1 diabetes mellitus · type 2 diabetes mellitus
Investigated by
Eli Lilly and Company

Trials 25

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 113 trials
Phase 1 NCT02197520 Jul 2014 → Jun 2015 type 2 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02152384 Jun → Dec 2014 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02109029 Apr 2014 → Mar 2015 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01995526 Dec 2013 → Jan 2014 — Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01925989 Nov 2013 → Oct 2015 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01771250 Oct 2013 → Dec 2014 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01871493 Jun → Sep 2013 — Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01877265 Jun → Sep 2013 — Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01818245 Mar → Jul 2013 — Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01784211 Feb → Nov 2013 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 22 trials · 1 met primary · 1 missed
Phase 2 NCT01049412 Jan → Dec 2010 type 1 diabetes mellitus Eli Lilly and Company Completed Met primary
Phase 2 NCT01027871 Jan → Dec 2010 type 2 diabetes mellitus Eli Lilly and Company Completed Missed primary
Phase 310 trials · 2 met primary
Phase 3 NCT02106364 Feb → Nov 2015 type 2 diabetes mellitus Eli Lilly and Company Withdrawn No outcome recorded
Phase 3 NCT02132637 May 2014 → Jul 2015 type 2 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT01894568 Jul 2013 → Apr 2015 type 2 diabetes mellitus Eli Lilly and Company Completed Met primary
Phase 3 NCT01790438 Mar 2013 → May 2014 type 2 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT01792284 Feb 2013 → Apr 2014 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT01582451 May 2012 → May 2013 type 2 diabetes mellitus Eli Lilly and Company Completed Met primary
Phase 3 NCT01454284 Jan 2012 → Feb 2014 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT01481779 Jan 2012 → May 2013 type 1 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT01468987 Dec 2011 → Aug 2013 type 2 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT01435616 Nov 2011 → Jan 2014 type 2 diabetes mellitus Eli Lilly and Company Completed No outcome recorded

News releases announcing trial results or a regulatory action · 11

DateIssuerRelease
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 ↗
Eli Lilly and Company's (NYSE: LLY) basal insulin peglispro (BIL) consistently demonstrated superior hemoglobin A1c (HbA1c) reduction in people with type 2 diabetes compared to insulin glargine across three Phase III trials.
2015-06-06 Eli Lilly and Company Results Basal Insulin Peglispro Studies Demonstrate Superiority to Insulin Glargine Across Multiple Measures in People with Type 1 Diabetes lilly.com ↗
In IMAGINE-1 and IMAGINE-3, BIL demonstrated superiority in HbA1c compared to insulin glargine.
2015-05-27 Eli Lilly and Company Results Lilly to Present New Clinical Data at 75th American Diabetes Association® Scientific Sessions lilly.com ↗
Basal Insulin Peglispro (BIL) is Superior to Insulin Glargine (GL) in Reducing HbA1c at 52 Weeks in Insulin-Naïve T2D Patients (Pts) Treated with Oral Antihyperglycemic Medications (OAMs): IMAGINE 2
2014-09-04 Eli Lilly and Company Results Lilly's Basal Insulin Peglispro Demonstrated HbA1c Superiority against Lantus® in Phase III Trials in Patients with Type 1 Diabetes lilly.com ↗
Notably, patients in IMAGINE-1 continued treatment beyond 26 weeks, and the HbA1c superiority for BIL was maintained at 52 and 78 weeks.
2014-06-14 Eli Lilly and Company Results Lilly's Basal Insulin Peglispro Shows Novel Mechanism of Action lilly.com ↗
When BIL and insulin glargine were each administered to achieve complete suppression of glucose production, which principally comes from the liver, BIL showed less activity in peripheral tissues, such as muscle and fat, than insulin glargine.
2014-05-12 Eli Lilly and Company Results Lilly's Basal Insulin Peglispro Shows Superiority in HbA1c Reduction Compared to Insulin Glargine in Three Phase III Trials in Patients with Type 2 Diabetes lilly.com ↗
INDIANAPOLIS, May 12, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive top-line results of three completed Phase III clinical trials in patients with type 2 diabetes for basal insulin peglispro (BIL), which is being studied as a once-daily treatment for both type 1 and type 2 diabetes.
2013-09-17 Eli Lilly and Company Results Lilly to Present Data Across its Diabetes Portfolio at the 49th European Association for the Study of Diabetes Annual Meeting lilly.com ↗
LY2605541 exhibits a flatter glucodynamic profile than insulin glargine at steady state in subjects with type 1 diabetes
2013-06-22 Eli Lilly and Company Results Follow-up Phase II Data Analysis Adds to Body of Evidence for Investigational Novel Basal Insulin, LY2605541 lilly.com ↗
The analysis provides more in-depth information about the reductions in required prandial (mealtime) insulin in LY2605541-treated patients compared to those treated with insulin glargine.
2012-10-02 Eli Lilly and Company Results Lilly and Boehringer Ingelheim Present Health Outcomes Data for Investigational Novel Basal Insulin Analogue lilly.com ↗
In addition to the reduction in nocturnal hypoglycaemia in LY2605541-treated patients, results showed the treatments had similar overall rates of hypoglycaemia (p=0.08, not statistically significant).
2012-09-24 Eli Lilly and Company Results Data from Boehringer Ingelheim and Lilly showcase strength of Diabetes Alliance at EASD Annual Meeting lilly.com ↗
Novel long-acting basal insulin analog LY2605541 significantly reduces nocturnal hypoglycemia and fear of hypoglycemia compared to insulin glargine in patients with type 2 diabetes mellitus
2012-06-11 Eli Lilly and Company Results Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine lilly.com ↗
Results of the type 1 diabetes study showed that LY2605541 was associated with greater improvements of glycemic control (lowering blood sugar levels) than insulin glargine.

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

FieldValueCited text
Known as insulin peglispro “Data on cytokeratin-18 (K-18) and enhanced liver fibrosis (ELF) score in insulin-treated diabetes patients with non-alcoholic fatty liver disease (NAFLD) are limited. This...” PMID 29167192 ↗ Nov 2017
9

“Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods.” NCT01925989 ↗

NCT01771250 ↗

NCT02197520 ↗

NCT02132637 ↗

NCT01894568 ↗

NCT02109029 ↗

NCT01995526 ↗

NCT02152384 ↗

NCT02106364 ↗

Known as BIL “Data on cytokeratin-18 (K-18) and enhanced liver fibrosis (ELF) score in insulin-treated diabetes patients with non-alcoholic fatty liver disease (NAFLD) are limited. This...” PMID 29167192 ↗ Nov 2017
Known as Insulina peglispro ChEMBL registry synonym — accepted as the source's own label CHEMBL2108569 ↗
Known as Insuline peglispro ChEMBL registry synonym — accepted as the source's own label CHEMBL2108569 ↗
Known as LY2605541 “Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods.” NCT01925989 ↗
17

“A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus” NCT02106364 ↗

NCT01481779 ↗

NCT01818245 ↗

NCT01871493 ↗

NCT01582451 ↗

NCT01784211 ↗

NCT01654380 ↗

NCT01468987 ↗

NCT01751399 ↗

NCT01792284 ↗

Show 7 more sources

Action Activate “Insulin receptor agonist” CHEMBL2108569 ↗
Modality Protein / enzyme biologic “novel long-acting basal insulin analog LY2605541” PMID 24198302 ↗ Nov 2013
Route Subcutaneous “subcutaneous injection of LY2605541” NCT01027871 ↗
Target INSR “Insulin receptor agonist” CHEMBL2108569 ↗