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A 52 week, Open Labelled, Randomised multi-centre 2 Arm Parallel Group Trial comparing Efficacy and Safety of Insulin Aspart, given in a Fixed Dose Regimen or in a Flexible Regimen, with or without In...

Update Il y a 4 ans
Reference: EUCTR2005-000319-87

A 52 week, Open Labelled, Randomised multi-centre 2 Arm Parallel Group Trial comparing Efficacy and Safety of Insulin Aspart, given in a Fixed Dose Regimen or in a Flexible Regimen, with or without Insulin Detemir in Subjects with Type 2 Diabetes

Woman and Man

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Extract

The primary objective of the trial is to compare the glycaemic control, measured as HbA1c after 52 weeks of treatment, in patients with type 2 diabetes treated with a supplementary insulin therapy (SIT+) being randomized either to a SIT+ fixed dose regimen or to a SIT+ flexible dose regimen including more intensive education and therapy control.

Inclusion criteria

  • type II diabetes mellitus

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