A trial comparing efficacy and safety of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs in subjects with type 2 diabetes

Update Il y a 4 ans
Reference: EUCTR2008-005767-34

Woman and Man

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Extract

To confirm the efficacy of SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c between SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors and insulin glargine OD + metformin ± pioglitazone ± DPP-4 inhibitors to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.


Inclusion criteria

  • Type 2 diabetes mellitus