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