Tag Archives: glargine U300

Novo Retracts CONCLUDE (H2H Tresiba vs. Toujeo) Press Release

Novo Nordisk announced the Danish Maritime and Commercial High Court ruled Novo’s September 19, 2019 press release regarding the full results from the CONCLUDE trial (H2H Tresiba vs. Toujeo in T2DM; view original press release here) violated the Danish Marketing Practices Act and the Danish Medicines Act. However, Novo did not disclose which specific portion of the September 2019 press release was in violation. In case you missed it, here is a link to FENIX’s insight on the CONCLUDE result following the presentation at EASD 2019.

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Thoughts on CONCLUDE (H2H Tresiba vs. Toujeo T2DM Basal-only Trial)

Novo Nordisk presented results at EASD from CONCLUDE, its Tresiba vs. Toujeo T2DM basal-only H2H study, and announced the results in a press release. While the trial failed to demonstrate a statistically significant benefit in the primary endpoint (severe or BG-confirmed symptomatic hypoglycemia), key secondary outcomes showed a clear benefit favoring Tresiba. It is a bit ironic that since the primary endpoint was not met, no conclusions can be made from the CONCLUDE secondary outcomes. Below, FENIX provides thoughts on the trial including a winners & losers analysis.

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