Category Archives: Insulin Delivery

Montreal dual-hormone AP System: Implications to Closed-Loop Development

A Montreal-based research group presented data at ADA on a dual-hormone artificial pancreas using both insulin and pramlintide. The study, presumed to be the clinical trial MAP-1, showed significantly improved glucose levels compared to an insulin-only artificial pancreas. Below, FENIX has provided context and insight regarding this study and its potential implications to the AP development space.

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New Fiasp/Medtronic 670G Study on CT.gov

A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.

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CGM Swapping Supported by Senseonics/Beta Bionics Partnership

Senseonics and Beta Bionics announced a new collaboration to integrate the Eversense implantable CGM with the iLet bionic pancreas. Below, FENIX analyzes the collaboration including statements from the companies that suggest iCGM systems can be switched between closed-loop systems.

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FENIX Analysis: Post-AACE 2018 Device Promotional Material

In the second installment of our post-AACE 2018 promotional material coverage (see first installment on diabetes drugs), FENIX has conducted an analysis of diabetes device promotional materials covering Dexcom G6, Abbott Freestyle Libre, Medtronic 670G, Insulet Omnipod, and Tandem t:slim X2.

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Insulet Omnipod DASH Cleared by FDA

Insulet has announced FDA 510(k) clearance of its next generation handheld personal diabetes manager (PDM) called “Omnipod DASH.” Below, FENIX provides insight into the DASH system including Insulet’s decision to give DASH away at no cost.

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Zealand Q1 ‘18 Earnings Update

Zealand hosted its Q1 ‘18 earnings call and provided updates on its diabetes portfolio including dasiglucagon. Additionally, Zealand discussed the potential of a priority review voucher (PRV) for dasiglucagon in congenital hyperinsulinism (CHI).

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Novo Nordisk Q1 ’18 Earnings Update

Novo hosted its Q1 ’18 earnings call (press release) and provided updates on its marketed and pipeline diabetes products. Of note, Novo discussed the relaunch of Tresiba based on the recent DEVOTE label update. Furthermore, Novo disclosed plans to initiate Ph2 for its QW basal insulin (LAI287) by YE ’18. Below are highlights from the call.

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Lilly Q1 ’18 Earnings Update

Lilly hosted its Q1 ’18 earnings call (press release) and provided updates on its diabetes business unit. Of note, Lilly affirmed REWIND (Trulicity CVOT) topline readout is anticipated in early Q4 ’18 with full results at ADA 2019. Below are highlights from the call.

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Common Sensing and Haselmeier Thoughts

Common Sensing announced close of $6.6M in Series A funding. Of note, Haselmeier joined this funding round as a new investor along with other venture capital firms which is curious since Haselmeier is an injection delivery device engineering company.

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New Lilly uRAI trials including H2H vs. Fiasp

Two new clinical trials for Lilly’s ultra-rapid-acting insulin lispro (LY900014; also called ultra-rapid lispro or “URLi” pronounced “early” [ur-lee] by Lilly at ATTD 2018), have been observed on CT.gov including a Ph1 H2H PK trial vs. Novo’s Fiasp and a Ph3 study in pumps called PRONTO-Pump.

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