Diamyd wins Swedish approval for follow-up study of diabetes vaccine

Published: 19-Feb-2009

To evaluate control of blood sugar, insulin requirement, quality of life and complications

Diamyd Medical, a biopharmaceutical company, has received approval from the Swedish Medical Products Agency to continue to follow the children who participated in the company's Phase II study of the Diamyd diabetes vaccine, which started four years ago.

The company said that it's been nearly four years since the children and adolescents were treated with the Diamyd vaccine, and now a three year follow-up will be offered. The children and adolescents will thus be followed for a total of seven years.

The aim of the follow-up is to confirm that treatment with Diamyd provides long-term clinical effect. The follow-up will evaluate control of blood sugar, insulin requirement, quality of life and diabetes complications.

Clinical studies have demonstrated that treatment with Diamyd halts or slows the destruction of the ability to produce insulin. The diabetes control and complications trial, a large American type 1 diabetes study, has demonstrated that a small amount of preserved endogenous insulin-producing capacity in patients with type 1 diabetes results in significantly better blood sugar control and reduces the risk of diabetes-related complications by more than 60%.

Elisabeth Lindner, president and CEO of Diamyd Medical, said: Clinical studies with Diamyd have demonstrated significant efficacy in preserving the body's own ability to produce insulin. We will now, in parallel with our ongoing large international Phase III trials, establish that the treatment also has the intended long-term effect in the patient's daily life.

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