Table A1.
Summary of trials included in the meta-analysis
| Trial | Trial description and treatment | Population | Antidiabetic therapy at screening | Duration (weeks) | Rand ratio | Number of subjects |
|---|---|---|---|---|---|---|
| 3579 | IDeg OD vs. IGlar OD (+ met ± DPP-4I) | T2DM insulin-naïve | Met monotherapy or Met + (SU ± α-GI ± DPP-4I in any combination) | 52 | 3:1 | IDeg: 773 IGlar: 257 |
| 3672 | IDeg 200 U/mL OD vs. IGlar OD (+ met ± DPP-4I) | T2DM insulin-naïve | Met monotherapy or Met + (SU/Glin ± α-GI ± DPP-4I in any combination) | 26 | 1:1 | IDeg: 228 IGlar: 229 |
| 3586 | IDeg OD vs. IGlar OD (+ OAD except DPP-4I) | T2DM insulin-naïve | Monotherapy (met or SU) or met + (SU ± α-GI ± DPP-4I) or SU + (α-GI ± DPP-4I) or met + SU + (α-GI or DPP-4I) | 26 | 2:1 | IDeg: 289 IGlar: 146 |
| 3668 | IDeg Flex vs. IGlar OD and IDeg Flex vs. IDeg OD (all arms ± OADs according to label) | T2DM insulin-naïve or basal-insulin-treated | OAD(s) only (any combination of met ± SU/glin ± PIO) or basal insulin only or basal insulin + OADs | 26 | 1:1:1 | IDeg FF: 229* IDeg: 228 IGlar: 230 |
| 3582 | IDeg OD vs. IGlar OD (+ IAsp TID ± met ± PIO) | T2DM insulin-treated | Any insulin regimen (with or without OADs) | 52 | 3:1 | IDeg 744 IGlar: 248 |
| 3583 | IDeg OD vs. IGlar OD (+ IAsp TID) | T1DM insulin-treated | Any basal-bolus regimen | 52 | 3:1 | IDeg: 472 IGlar: 157 |
| 3770 | IDeg Flex vs. IGlar OD and IDeg Flex vs. IDeg OD (all arms + IAsp TID) | T1DM insulin-treated | Any basal insulin (OD or BID) + any bolus injection (≥3 daily injections) | 26 | 1:1:1 | IDeg FF: 164* IDeg: 165 IGlar: 164 |
α-GI, alpha glucosidase inhibitor; BID, twice daily; DPP-4I, dipeptidyl peptidase 4 inhibitor; FF, fixed flexible (flexible dosing arm); Flex, flexible; Glin, glinides; IAsp, insulin aspart; IDeg, insulin degludec; IGlar, insulin glargline; OAD, oral antidiabetic drug; OD, once daily; met, metformin; PIO, pioglitazone; Rand ratio, randomization ratio; SU, sulfonylureas; TID, thrice daily; T2DM, type 2 diabetes mellitus; T1DM, type 1 diabetes mellitus.
*
The flexible dosing arms of Trials 3668 and 3770 were excluded from this meta-analysis as this regimen does not reflect the intended use of IDeg in clinical practice.