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Table 1 Overview of the therapeutic confirmatory trials of degludec in patients with Type 1 and Type 2 diabetes mellitus

From: Degludec: the new ultra-long insulin analogue

Trial Population Therapy Treatment arms Treatment combination Duration (Weeks) Treatment at screening
3582 Insulin-treated T2D Basal-bolus Degludec OD + Aspart 52 Any insulin regimen
versus ± Met (Extension of 26 wks)
Glargine OD ± Pio  
3579 Insulin-naïve Insulin + OADs Degludec OD + Met 52 Met (mandatory) ± SU, ±a-GI, ± DPP-4i in any combination
T2D   versus ± DPP-4i (Extension of 52 wks)
Glargine OD
3672 Insulin-naïve Insulin + OADs Degludec OD + Met 26 Met (mandatory) ± SU, ± α-GI, ± DPP-4i in any combination
T2D   versus ± DPP-4i
Glargine OD  
3586 Insulin-naïve Insulin + OADs Degludec OD ± Met 26 Monotherapy or combination of SU and Met ± α-GI, or DPP-4i
T2D   versus ± SU
Glargine OD ± α-GI
3580 Insulin-naïve Insulin + OADs Degludec OD +1-2 ADOs: Met, SU, Pio 26 ± Met, ± SU, ± pio 1–2 OADs in any combination
T2D   versus  
Sitagliptin OD
3668 Insulin-naïve + insulin -treated Insulin + OADs Degludec Fixed Flex OD versus ± Met 26 OADs only or basal insulin only or basal insulin + OADs (any combination of Met, SU or Pio)
T2D   Glargine OD and Degludec Fixed Flex OD ± SU
versus ± Pio
Degludec OD
3583 Insulin- treated Basal-bolus Degludec OD + Aspart 52 Any basal-bolus regimen
T1D   versus   (Extension of 52 wks)
Glargine OD
3585 Insulin- treated Basal-bolus Degludec OD + Aspart 26 Any basal-bolus regimen
T1D   versus   (Extension of 26 wks)
Detemir OD
3770 Insulin- treated Basal-bolus Degludec Fixed Flex OD + Aspart 26 Any basal-bolus regimen
T1D   versus   (Extension of 26 wks)
Glargine OD and Degludec Fixed Flex OD versus
Degludec OD
  1. α-GI alpha-glucosidase inhibitor, Dpp-4i dipeptidyl peptidase-4 inhibitor, Met metformin, OADs oral antidiabetic drugs, OD once daily, Pio pioglitazone, SU sulphonylurea, T1D type 1 diabetes, T2D Type 2 diabetes, Wks weeks