MedWatch

Diabetes company brings European phase III trial forward as US troubles continue

Diamyd Medical has moved up its phase III start date in Europe to avoid potential delays in the patient recruitment process caused by the partial clinical hold in the US, which was implemented by the FDA in September.

Photo: Diamyd Medical / PR

It was a letdown for Diamyd Medical, which is based in Stockholm, when the the US Food and Drug Administration (FDA) last month placed the company's phase III trial under a "partial clinical hold." The FDA said it couldn't approve all parts of the Swedish company's application to begin the study.

The large phase III trial, named diagnode-3, is planned to take place in the US in addition to a string of European clinics. However, to avoid recruitment timeline shifts due to the US obstacle, Diamyd Medical has accelerated its plans in Europe, having previously planned to begin testing here concurrently with the US trials, or later.

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