Tag Archives: Diabetes

BI Partners With Yale for HF Digital Solutions Trial; New Lilly Lyumjev T1DM TIR Study; Roche Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: Boehringer Ingelheim and Yale announced a collaboration to evaluate heart failure digital technologies (press release); Lilly initiated new Lyumjev (ultra rapid-acting lispro) + degludec U100 T1DM MDI TIR study; and Roche hosted its Q3 ’20 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how the new Lilly Lyumjev trial likely relates to the recent educational partnership between Lilly and Dexcom (previous FENIX insight).

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Medtronic 2020 Investor Day Highlights

Medtronic hosted its 2020 Investor Day (view slides) and provided updates across its business, including plans to reinvigorate its diabetes business. Importantly, Medtronic disclosed that just yesterday (October 13), the company completed enrollment in its next-gen Synergy CGM sensor pivotal trial. Below, FENIX provides highlights and insights from the diabetes-related portion of the event.

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Two New Novo Ph1 QW Icodec Trials

Two new Ph2 trials for Novo Nordisk’s QW insulin icodec have recently been observed on CT.gov, including a PK/PD study evaluating insulin icodec in patients after being run in on insulin degludec (NCT04582435) and a PK study comparing different injection sites (NCT04582448). Both Ph1 icodec trials are scheduled to initiate ahead of the Ph3 program, which is expected to start in November 2020. Below, FENIX provides an overview and thoughts on the two trials, including readthough to Novo’s QW fixed-ratio combination, icosema (icodec+ QW injectable semaglutide).

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Dario Included in Vitality’s Gateway Flex Program; J&J Q3 ’20 Earnings Update

Dario announced it has been chosen for inclusion in Vitality’s new Gateway Flex offering. J&J also hosted its Q3 ’20 earnings call (press release; slides), and unsurprisingly, there was significant discussion surrounding the recent pause on J&J’s COVID-19 vaccine trial due to an unknown illness in one of the trial participants (view statement from J&J). Below, FENIX provides insight into the impact of Gateway Flex on Dario’s business as well as diabetes-related financial highlights from the J&J earnings call.

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DAPA-HF CHMP Opinion This Week?; October 12-15 CHMP Agenda

The CHMP agenda for this month (October 12-15) has been released, and it includes one notable item, DAPA-HF, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the October 2020 CHMP agenda.

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Novo Launches the First Rybelsus Video DTC campaign; New Omnipod DTC from Insulet

Two new DTC commercials have recently been observed: Novo Nordisk launched a Rybelsus video DTC called “Wake Up” and Insulet initiated an Omnipod video DTC called “Simplify Life with Omnipod.” Of note, this is the first Rybelsus video DTC to be observed since the Rybelsus US approval in September 2019. Below, FENIX provides analyses for both of the DTC commercials, including insight into the ongoing Rybelsus launch.

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Lilly and Dexcom Partner to Promote Lyumjev and G6 CGM; Omar Ishrak to Retire from Medtronic; Patia BioPharma and Precision Diabetes Partner for Diabetes Diagnostics; Capillary Bio Receives $1.5M Loan from Helmsley

A series of diabetes-related news items have been observed: Lilly and Dexcom announced a partnership to launch a joint program for US HCPs, focusing on Lyumjev and G6 CGM’s role in PPG control; Medtronic announced its former CEO, Omar Ishrak, will retire as Executive Chairman and Chairman of the Board, succeeded by CEO, Geoff Martha; Patia Biopharma and Precision Diabetes announced a partnership for diabetes diagnostics; and Capillary Biomedical announced it has received a $1.5M loan from the Helmsley Charitable Trust to conduct trials for an extended-wear infusion set. Below, FENIX provides highlights and insights from the respective news items.

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Sotagliflozin, Finerenone, and Omecamtiv CVOTs @ AHA 2020

The AHA 2020 late-breaking abstract titles have been published and include the sotagliflozin (SOLOIST-WHF and SCORED), finerenone (FIDELIO-DKD), and omecamtiv mecarbil (GALACTIC-HF) CVOTs (view all AHA late-breaking topics here). Recall, Bayer announced positive topline results from FIDELIO-DKD in July 2020 (previous FENIX insight). Lexicon has not released any topline results from the SOLOIST-WHF and SCORED trials, which were closed out early following the Sanofi partnership dissolution (previous FENIX insight). As such, the SCORED and SOLOIST-WHF results are highly anticipated.

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Senseonics Files 180-Day Implantable CGM sPMA; Beyond Type 1 Launches Insulin Affordability Resource; KDIGO Releases New 2020 T2DM+CKD Guidelines

A series of diabetes-related news items have been observed: Senseonics announced the sPMA filing of its 180-day implantable CGM; Beyond Type 1 launched GetInsulin.org as a tool to connect PWD to insulin assistance programs and low-cost insulin solutions (press release); and Kidney Disease: Improving Global Outcomes (KDIGO) recently released its first-ever T2DM CKD guidelines, called 2020 Clinical Practice Guideline for Diabetes Management in CKD (view press release; view complete document here). Below, FENIX provides highlights and insight from the respective news items.

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