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An extension trial to NN1250-3582 comparing safety and efficacy of NN1250 and insulin glargine, both with insulin aspart as meal-time insulin ± OADs in type 2 diabetes A 26 week controlled, open lab...

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Reference: EUCTR2009-015816-17

An extension trial to NN1250-3582 comparing safety and efficacy of NN1250 and insulin glargine, both with insulin aspart as meal-time insulin ± OADs in type 2 diabetes A 26 week controlled, open label, multicentre, multinational, treat-to-target extension trial comparing safety and efficacy of SIBA and insulin glargine both administered once daily in a basal-bolus regimen with insulin aspart as mealtime insulin ± treatment with metformin, ± pioglitazone in subjects with type 2 diabetes after a preceding 52 week treatment period with SIBA or insulin glargine both with mealtime insulin aspart ± treatment with metformin, ± pioglitazone in trial NN1250-3582

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Extract

The primary objective of this extension trial is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 + insulin aspart ± metformin ± pioglitazone to insulin glargine + insulin aspart ± metformin ± pioglitazone after 78 weeks of treatment (52 weeks of treatment in NN1250-3582 plus 26 weeks of treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events. • Hypoglycaemic episodes. • Clinical evaluation. • Central laboratory assessments. • Body weight. • Insulin dose.

Inclusion criteria

  • Type 2 Diabetes

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