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A 26-week trial comparing efficacy and safety of insulin degludec/insulin aspart BID and insulin degludec OD plus insulin aspart in subjects with type 2 Diabetes Mellitus treated with basal insulin in...

Update Il y a 4 ans
Reference: U1111-1130-7135

A 26-week trial comparing efficacy and safety of insulin degludec/insulin aspart BID and insulin degludec OD plus insulin aspart in subjects with type 2 Diabetes Mellitus treated with basal insulin in need of treatment intensification with mealtime insulin

Woman and Man

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Extract

The objective of this trial is to confirm the efficacy of IDegAsp BID in controlling glycaemia after 26 weeks of treatment. This is done by comparing the difference in change in glycosylated haemoglobin (HbA1c) between IDegAsp BID ± OADs and IDeg OD plus IAsp 2-4 times daily ± OADs to a non-inferiority limit of 0.4%, in accordance with draft Guidance for Industry Diabetes Mellitus, Food and Drug Administration (FDA) 2008

Inclusion criteria

  • Diabetes Mellitus, Type 2

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